MPharm template submission - pharmacyregulation.org · Web viewMCA, DA and/or combined programme(s) submission template - for events in the 2018-19 academic year 50. M

Accreditation of unregistered pharmacy staff training programme(s): submission template (parts 1 & 2)

This template should be used to demonstrate how the provider meets the GPhC’s accreditation criteria for accreditation of an unregistered pharmacy staff training programme(s). Programmes may include Medicines Counter Assistant (MCA), Dispensing Assistant (DA) (including subsidiaries of) and/or combined programme(s).

The accreditation submission document should be a single document which includes: An introduction and scene setting. An overview of how the programme has developed since the last accreditation, including a

summary of any major changes. (reaccreditation only) An explanation of how any conditions and recommendations from the previous event have

been addressed including supporting evidence where appropriate. (reaccreditation only) An explanation of the rationale for this decision should be provided where a provided opted

not to action a recommendation. (reaccreditation only) Information on the number of trainees that have successfully passed the programme(s) since

the last event. (reaccreditation only) Projected number of trainees on the programme(s). This template, completed in full, to include:

- A narrative explaining how each criterion is met. The narrative must be written in prose, clearly explaining how the criteria will be met.

- Reference to links, file names, or module titles on their own are not acceptable. - Full reference to the documents you are providing as evidence.

You should provide documentary evidence to support the information that you have provided within the template. No additional documents should be provided. Please see the guidance given throughout this template which details the evidence that you need to provide. Following review of your submission document and associated evidence you may be required to submit additional items of evidence. If this is necessary you will be notified in advance of your accreditation event.

Please ensure that you provide your submission in the correct format with the required level of detail and clarity. Failure to do so could lead to your accreditation event being cancelled or postponed. Information on how to submit your documentation can be found on the last page of this document.

If you have any questions regarding your accreditation submission please contact the GPhC’s Quality Assurance (Education) team at [email protected]

mailto:[email protected]

Academic year: 2018-19

Name of Provider:

Contact name:

Job title:

Address:

Telephone:

Mobile:

Email:

MCA, DA and/or combined programme(s) submission template - for events in the 2018-19 academic year 2

Important – please read the guidance below before completing the template

General notes regarding completion of the template

Your commentary must be written in prose, except where single piece information or lists are asked for. Directions to other documents only will not be accepted.

Any diagrams or images should be submitted as documentary evidence and not embedded within the tables.

Hyperlinks may be used within your commentary to signpost to evidence, but please check that the links are not broken and that external access is permitted.

Please ensure that all documentary evidence provided is referred to within your commentary. Supporting documents should be included as appendices and should be provided separately

from the submission template. Each module must be referred to by its full title and not by module code. Should your commentary relate to more than one criterion, it does not need to be repeated.

Simply include a note referencing to the relevant commentary, e.g. ‘please refer to commentary under criterion 1.2’.

Referencing documentary evidence

Please give each piece of evidence a clear and meaningful title. For ease of reference, supporting documents should be numbered accordingly.

The document title referred to in your commentary should be identical to the name of the relevant .PDF file you have provided.

Please ensure that all file names are concise and do not contain any special characters including: / \ : * ? ” < > | # { } % ~ &

You do not need to duplicate evidence - you may find that you need to refer to one piece of documentary evidence multiple times across more than one section.

When referencing supporting documents within the submission, please indicate the document clearly (for example, in bold) and use the full name and appendix number throughout.

NB. When completing your submission, please do not alter the formatting or orientation of the submission template.

Applying for accreditation of unregistered pharmacy staff training programme(s).

If you are applying for accreditation of two or more programmes to be reviewed as a combined event, you will need to submit a separate submission for each programme but you do not need to repeat your commentary.

We would advise that you complete the submission template for the largest programme first. Only information that is additional or different on the additional programme(s) needs to be

entered onto a separate submission. Please ensure all units are clearly mapped to the individual programme seeking accreditation. Any units which are not covered by your training programme should be deleted. The GPhC is committed to compliance with the General Data Protection Regulation (GDPR),

details for our privacy policy can be found on our website - https://www.pharmacyregulation.org/privacy-policy


https://www.pharmacyregulation.org/privacy-policy

Submission template part 1: meeting the accreditation criteria

Introduction

Your introduction must include:

An introduction and scene setting. An overview of how the programme has developed since the last accreditation, including a

summary of any major changes. (reaccreditation only) An explanation of how any conditions and recommendations from the previous event have been

addressed, including supporting evidence where appropriate. (reaccreditation only) Where a provider opted not to action a recommendation, an explanation of the rationale for this

decision should be provided. (reaccreditation only) Information on the number of trainees who have undertaken/are undertaking the programme.

(reaccreditation only) Projected number of trainees.

Provider’s commentary

Please type your commentary hereXX

Accreditation criteria

Criteria 1: The training programme

1.a For the MCA provision, the programme content is mapped to unit 4 (SFHPHARM04), unit 5 (SFHPHARM07) and unit 15 (SFHPHARM32).

Please provide commentary on how to evidence the following The specific units covered mapped to the programme. The module or unit titles. The phasing or sequence of the modules or units in the programme.

***Please delete these guidance sections before submitting your template to the GPhC***



Accreditation team’s commentary

For accreditation team use only

1.b For the DA provision, the unit(s) are relevant, specific and mapped clearly to the programme being developed.

Please provide commentary on how to evidence the following:


Course summary to include module or unit titles and the phasing or sequence of the modules or units in the programme.

Specify units covered.




For accreditation use only

1.c For the MCA and DA ‘combined’ provision, the programme content is mapped to unit 4 (SFHPHARM04), unit 5 (SFHPHARM07) and unit 15 (SFHPHARM32) and additional units are relevant, specific and mapped clearly to the programme being developed.

Please provide commentary on how to evidence the following: Course summary to include module or unit titles and the phasing or sequence of the modules or

units in the programme. Specify units covered.





1.d The programme(s) is (are) aligned and thought to the Pharmacy National Occupational Standards (NOS) at RQF level 2 / SCQF level 5 or equivalent.

Please provide commentary on how to evidence the following: Summary of activities and assessments including assessment methods.





1.e For each unit, the transfer of underpinning knowledge into the workplace is demonstrated through the use of a variety of methods.

Please provide commentary on how to evidence the following: Evidence of how this person(s) has/have contributed to the design of the programme and will

contribute to its delivery.






1.f Assessments have been developed by subject experts from the Pharmacy sector and directly relate to the relevant units of the Pharmacy National Occupational Standards (NOS) at RQF level 2 / SCQF level 5 or equivalent.

Please provide commentary on how to evidence the following: Provide details of individuals, course panel or equivalent group responsible for the development of

the programme. CVs should be provided (see documentary evidence).





Additional information on the training programme.Please provide commentary on how to evidence the following:

How the course is delivered Total expected student workload (guided learning hours), number of curriculum hours for each part

of the course, contact time with training provider. Anticipated duration of the training programme including maximum and minimum permitted

durations. How the training programme(s) is funded.





Section 2: Academic and management structures

2.a Assessment process and strategies assure appropriate standards in assessment and that students are able to demonstrate fitness for purpose.

Please provide commentary on how to evidence the following: Information on the management of quality assurance procedures. Details of marking criteria, how marking is done and by whom, measures to ensure consistency,

how borderline issues are dealt with. Course regulations covering re-sits, resubmissions and extenuating circumstances including

rationale.





2.b In the processes of programme review and development, the training provider has taken account of advances in pharmacy practice and developments potentially


impacting on pharmacy.

Please provide commentary on how to evidence the following: Details of how the course will be reviewed and details of individuals, course panel or equivalent

group responsible for the review and how any changes will be disseminated to students. CVs should be provided (see documentary evidence).





2.c Course regulations include procedures for appeals against assessment decisions.

Please provide commentary on how to evidence the following: Course regulations and procedures for appeals against assessment decisions.





2.d Course regulations include procedures for dealing with suspected plagiarism and/or malpractice.

Please provide commentary on how to evidence the following: Course regulations and procedures for dealing with suspected malpractice/plagiarism.





Additional information on your academic and management structures.

Please provide commentary on how to evidence the following: Provide additional information on your academic and management structures not covered in

criteria






Section 3: Resources

3.a Buildings, human, equipment, and other resources available to the training provider are sufficient for the effective delivery of the course to the numbers of students on the course, and overall.

Please provide commentary on how to evidence the following: Information on the management of quality assurance procedures. Details of marking criteria, how marking is done and by whom, measures to ensure consistency,

how borderline issues are dealt with. Information on how the programme was benchmarked against the Pharmacy National

Occupational Standards (NOS) at RQF level 2 / SCQF level 5 or equivalent. Information on human resources including numbers with names of staff associated with the training

programme(s) with descriptions of their roles, qualifications/credentials backgrounds and contractual status in relation to the training provider. CVs should be provided (see documentary evidence).

Information on equipment and support services. Current and planned annual intakes. Admissions policy and marketing strategy. Commentary on completion and success rates of students on this course, or a similar programme if

this is a new course.





3.b Record keeping systems are able to generate data on candidates completing, completion rates, student sector of practice, and disability.

Please provide commentary on how to evidence the following: Information on record keeping systems. Evidence of compliance with relevant UK legislation and guidance around disability and protected

characteristics.





3.c Systems are in place for issuing certificates of completion to successful students in the GPhC’s approved format.

Please provide commentary on how to evidence the following: Information on record keeping systems. Evidence of compliance with relevant UK legislation and guidance around disability and protected

characteristics. Confirmation that systems are in place for the issuing of certificates to successful trainees. The certificate must refer to the fact that the course is accredited by the General Pharmaceutical

Council. The units of the Pharmacy National Occupational Standards (NOS) at RQF level 2 / SCQF


level 5 or equivalent. The certificate(s) must use the full unit titles.





3.d There is an appropriate mix of tutors, mentors and assessors.

Please provide commentary on how to evidence the following: Information on who is responsible for tutoring, mentoring and assessing the student. Clarify roles and responsibilities of the training provider and others, for instance the workplace

supervising pharmacist and what support is provided by the training provider for those supporting the student.





3.e The student has access to a personal tutor or tutors for academic guidance and pastoral care.

Please provide commentary on how to evidence the following: Description of student access to tutors and mentors including who is the tutor and how tutors are

accessed by the student for instance face to face, online, telephone.





3.f The student is instructed in the use of information resources.

Please provide commentary on how to evidence the following: Information provided to students on available resources.





3.g There are adequate student feedback mechanisms in place.

Please provide commentary on how to evidence the following:


Evidence of two-way communication between course provider and students. Details of student feedback mechanisms, for instance questionnaires, and how the information

gathered informs course development. Description of mechanisms for feeding back to students on performance.





3.h The training provider seeks to provide the student with a positive learning experience.

Please provide commentary on how to evidence the following: Information about how the is student supported and support given to tutors and mentors.





Additional information on your resourcesPlease provide commentary on how to evidence the following:

How the training programme is funded Information about the range of education and training provided, including modes of delivery. Brief details of all training packages marketed to unregistered pharmacy staff.






Submission template part 2: unregistered staff training programme(s) mapping

Please demonstrate how the training programme has been designed to meet one or more units of the Pharmacy National Occupational Standards (NOS) at RQF level 2 / SCQF level 5 or equivalent.

Any units which are NOT covered by your training programme should be DELETED.

1. Assist with the provision of a pharmacy service

General Pharmaceutical Council (GPhC) Learning Outcomes

To demonstrate knowledge and understanding in this NOS, assistants should be able to apply:

Name of document and unit/module number Accreditation team use only

1.1 A working knowledge of the Standard Operating Procedures and the importance of adhering to them at all times


Please type your commentary hereXX (expand as necessary)



1.2 A working knowledge of the importance of working within the limits of your competence and authority, when to seek agreement or permission from others and when to refer on to an appropriate person

1.3 A working knowledge of the current health and safety legislation and how it applies to the working environment


1.4 A working knowledge of the legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being carried out

1.5 A working knowledge of the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed

1.6 A working knowledge of the importance of adhering to information governance policies and maintaining confidentiality when sharing information about individuals with others

1.7 A working knowledge of the duty to report any acts or omissions that could be detrimental to individuals, yourself, colleagues or your employer

1.8 A working knowledge of what constitutes good customer service

1.9 A working knowledge of the organisation's policy on the service provided to individuals and how this applies to your role

1.10 A working knowledge of the organisation's procedure for handling complaints

1.11 A working knowledge of how to assess complaints and what action to take

1.12 A working knowledge of when you should refer complaints and to whom

1.13 A working knowledge of the methods of enabling effective communication and supporting individuals to communicate their needs, views and preferences


1.14 A working knowledge of the importance of establishing the requirements of individuals clearly and accurately

1.15 A working knowledge of the importance of collecting the relevant information about the individual and their problem

1.16 A working knowledge of the importance of verbal and non-verbal communication when communicating with individuals

1.17 A working knowledge of how to give clear and accurate information and check the individual's understanding

1.18 A working knowledge of how to manage conflict and/or individuals who are distressed

1.19 A working knowledge of the relevant products and services or advice for which information and/or advice is required

1.20 A working knowledge of the where to get assistance if you cannot provide information and advice yourself

1.21 A working knowledge of the source(s) of information that can be accessed and the information that can be given to individuals by you and other colleagues

1.22 A working knowledge of the importance of recording, storing and retrieving information in accordance with organisational procedures

2 Make sure your own actions reduce risks to health and safety





2.1 A working knowledge of what ‘hazards’ and ‘risks’ are





2.2 A working knowledge of what their own responsibilities and legal duties for health and safety in the workplace

2.3 A working knowledge of their own responsibilities for health and safety as required by the law covering their job role

2.4 A working knowledge of the hazards which exist in their workplace and the safe working practices which they must follow

2.5 A working knowledge of the particular health and safety hazards which may be present in their own job and the precautions they must take

2.6 A working knowledge of the importance of remaining alert to the presence of hazards in the whole workplace

2.7 A working knowledge of the importance of dealing with, or promptly reporting risks

2.8 A working knowledge of the responsibilities of health and safety in their job description


2.9 A working knowledge of the safe working practices for their own job role

2.10 A working knowledge of the responsible people they should report health and safety matters to

2.11 A working knowledge of where and when to get additional health and safety assistance

2.12 A working knowledge of their own scope and responsibility for controlling risks

2.13 A working knowledge of workplace instructions for managing risks which they are unable to deal with

2.14 A working knowledge of suppliers’ and manufacturers’ instructions for the safe use of equipment, materials and products which they must follow

2.15 A working knowledge of the importance of personal presentation in maintaining health and safety in their workplace

2.16 A working knowledge of the importance of personal behaviour in maintaining the health and safety of themselves and others

3 Contribute to the effectiveness of teams


To demonstrate knowledge and Name of document and unit/module number Accreditation team use only


understanding in this NOS, assistants should be able to apply:

3.1. A working knowledge of legal and organisational requirements on equality, diversity, discrimination and rights when working in teams





3.2. A working knowledge of codes of practice and conduct, standards and guidance relevant to their own roles, responsibilities, accountability and duties of others when working in teams to support individuals

3.3. A working knowledge of current local, UK and European legislation, and organisational requirements, procedures and practices for:a) Accessing recordsb) Recording, reporting, confidentiality and sharing information, including data protectionc) Team working

3.4. A working knowledge of how to access up-to-date copies of the organisation’s workplace policies, procedures and systems, and practice and service standards related to team working

3.5. A working knowledge of the principles that underpin effective team working

3.6. A working knowledge of individuals’ styles of interaction and how these can affect team working


3.7. A working knowledge of barriers to developing relationships within the team and how these can be overcome

3.8. A working knowledge of problems which may be encountered when relating to and interacting with other team members and how these can be best handled

3.9. A working knowledge of their own strengths and weaknesses as an individual worker and as a team member

3.10. A working knowledge of development and learning opportunities available to support them in team working and activities

4 Provide advice on non-prescribed medicines and products




4.1. A working knowledge of the Standard Operating Procedures and the importance of adhering to them at all times






4.2. A working knowledge of the importance of working within the limits of your competence and authority, when to seek agreement or permission from others and when to refer on to an appropriate person

4.3. A working knowledge of the current health and safety legislation and how it applies to the working environment

4.4. A working knowledge of the legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being carried out

4.5. A working knowledge of the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed

4.6. A working knowledge of the importance of adhering to information governance policies and maintaining confidentiality when sharing information about individuals with others

4.7. A working knowledge of the duty to report any acts or omissions that could be detrimental to individuals, yourself, colleagues or your employer

4.8. A working knowledge of the methods of enabling effective communication and supporting individuals to communicate their needs, views and preferences

4.9. A working knowledge of the when and how to use the relevant protocols for the safe sale of medicines

4.10. A working knowledge of the main actions and side effects of the active ingredients within


the most commonly used non-prescription medicines

4.11. A working knowledge of the different classes of medicines

4.12. A working knowledge of the interactions, cautions and contraindications of commonly used non-prescribed medicines

4.13. A working knowledge of the which medicines or products are liable to misuse or abuse by individuals

4.14. A working knowledge of the how to give advice on the appropriate use of non-prescribed medicines and products

4.15. A working knowledge of the how to maintain the privacy of the individual when asking questions related to their needs

4.16. A working knowledge of the use of appropriate questioning techniques to obtain relevant information

4.17. A working knowledge of the divergent needs of individuals

4.18. A working knowledge of the sources of information that can be accessed and the information that can be given to individuals by you and other colleagues

4.19. A working knowledge of the when you should refer for information/advice and to whom

4.20. A working knowledge of the importance of recording, storing and retrieving information in accordance with organisational procedures


5 Receive prescriptions




5.1 A working knowledge of the Standard Operating Procedures regarding the receiving and retrieving of prescriptions and the importance of adhering to them at all times






5.3 A working knowledge of the current legislation relating to prescription charges and exemptions and differences in practice across the UK


5.5 A working knowledge of the relevant national and local guidelines, policies and procedures


that are available and how and when they should be accessed



5.8 A working knowledge of regulations and procedures relating to different types of prescriptions and medicines

5.9 A working knowledge of methods of enabling effective communication and supporting individuals to communicate their needs, views and preferences

5.10 A working knowledge of the different types of prescribers

5.11 A working knowledge of the different types of prescriptions and when they are used

5.12 A working knowledge of the different ways of receiving prescriptions

5.13 A working knowledge of the details required on a prescription and why they are necessary

5.14 A working knowledge of exemptions and how individuals can claim refunds, including the use of official forms and prepayment certificates

5.15 A working knowledge of the transactional and administration procedures as required by government regulations and those that apply to your workplace



6 Assemble prescribed items




6.1. A working knowledge of the Standard Operating Procedures and the importance of adhering to them at all times





6.2. A working knowledge of the importance of working within the limits of your competence and authority, when to seek agreement or permission from others and when to refer on to an appropriate person

6.3. A working knowledge of the current health and safety legislation and how it applies to the working environment

6.4. A working knowledge of the legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being carried out


6.5. A working knowledge of the relevant national and local guidelines, policies and procedures that are available and how and when they should be accessed

6.6. A working knowledge of the importance of adhering to information governance policies and maintaining confidentiality when sharing information about individuals with others

6.7. A working knowledge of the duty to report any acts or omissions that could be detrimental to individuals, yourself, colleagues or your employer

6.8. A working knowledge of the importance of personal hygiene and correct use of protective clothing

6.9. A working knowledge of the importance of maintaining a clean working environment and equipment

6.10. A working knowledge of the factors which cause deterioration of stock

6.11. A working knowledge of the sources of contamination and appropriate corrective action

6.12. A working knowledge of the prescribing conventions, abbreviations and medical terminology

6.13. A working knowledge of the proprietary and generic names of medicines within your scope of practice

6.14. A working knowledge of how medicines are administered

6.15. A working knowledge of the different strengths, forms, doses and quantities of medicines, and why they are used and how to


calculate them

6.16. A working knowledge of the different stages of the checking procedure

6.17. A working knowledge of the how to identify near misses and dispensing errors

6.18. A working knowledge of the causes and consequences of near misses and dispensing errors

6.19. A working knowledge of the local and/or national error reporting procedures and communication channels

6.20. A working knowledge of the importance of selecting the correct equipment for use

6.21. A working knowledge of the properties of different types of container types and when to use each

6.22. A working knowledge of the safe handling and storage of hazardous material and procedures to minimise risk

6.23. A working knowledge of the processes for reconstitution

6.24. A working knowledge of the labelling requirements and conventions

6.25. A working knowledge of when and why patient medication records are used

6.26. A working knowledge of the importance of recording, storing and retrieving information in accordance with organisational procedures

7 Order pharmaceutical stock














7.6 A working knowledge of the importance of adhering to information governance policies and maintaining confidentiality when sharing


information about individuals with others


7.8 A working knowledge of the different procurement processes and legislation that applies to the ordering of pharmaceutical stock

7.9 A working knowledge of your responsibilities and current guidelines that apply when ordering pharmaceutical stock

7.10 A working knowledge of the difference between proprietary and generic medicines

7.11 A working knowledge of the different forms of medicines and why it is important to order appropriate quantities of the correct form and strength

7.12 A working knowledge of how to place an order with the appropriate supplier

7.13 A working knowledge of the importance of ensuring that stock is available based on the needs of individuals

7.14 A working knowledge of the impact stock availability may have on the care of individuals

7.15 A working knowledge of the importance of taking account of seasonal variations when ordering pharmaceutical stock

7.16 A working knowledge of the action to be taken if stock is unavailable

7.17 A working knowledge of the input and retrieval of stock data to ensure levels are appropriate for stock management



8 Receive pharmaceutical stock











8.4 A working knowledge of the legal, organisational and policy requirements relevant to your role, the role of others in your


organisation and the activities being carried out




8.8 A working knowledge of the current guidelines that apply to the receipt of pharmaceutical stock

8.9 A working knowledge of the different forms of medicines and why it is important to stock appropriate quantities of the correct form and strength

8.10 A working knowledge of the importance of how receiving the correct form and quantity of stock can affect the care of individuals

8.11 A working knowledge of the importance of referring to current drug alerts and company recalls when receiving pharmaceutical stock

8.12 A working knowledge of the sources and suppliers of stock

8.13 A working knowledge of the equipment used when receiving pharmaceutical stock

8.14 A working knowledge of the action to be taken if received stock:a) is not on the original orderb) is not the complete order


c) is short dated or expiredd) has the wrong batch numbere) has a batch number for which drug alerts/recalls have been issuedf) is damaged, contaminated or suspected to be counterfeitg) has not been stored correctly during transportation

8.15 A working knowledge of the action to be taken if stock is unavailable

8.16 A working knowledge of how to promptly inform the appropriate person of the availability of the stock where the goods received are for a special or outstanding order

8.17 A working knowledge of the storage requirements of different types of products and why they are important

8.18 A working knowledge of the importance of stock rotation and the safe storage of stock

8.19 A working knowledge of how to receive an order into stock

8.20 A working knowledge of the input and retrieval of stock data to ensure levels are appropriate


9 Maintain pharmaceutical stock















9.7 A working knowledge of the duty to report any acts or omissions that could be


detrimental to individuals, yourself, colleagues or your employer

9.8 A working knowledge of the current guidelines that apply to maintaining pharmaceutical stock

9.9 A working knowledge of the different forms of medicines and why it is important to stock appropriate quantities of the correct formulation and strength

9.10 A working knowledge of the action to take immediately when drug alerts and company recalls are received

9.11 A working knowledge of the importance of monitoring and maintaining a safe, secure and clean environment

9.12 A working knowledge of the storage requirements of different types of products and why they are important

9.13 A working knowledge of the importance of good stock management, including:a) the rotation of stockb) checking expiry dates of stockc) the quantity of stock, taking account of seasonal variationsd) identifying damaged, contaminated or deteriorated stock

9.14 A working knowledge of the importance of taking appropriate action if stock is unavailable

9.15 A working knowledge of the action to be taken if stock:a) is short dated or expiredb) is damaged or contaminatedc) has a batch number for which drug


alerts/recalls have been issuedd) has been returned to the pharmacy

9.16 A working knowledge of the procedures for the safe handling and disposal of waste materials

9.17 A working knowledge of how automation is used to control stock

9.18 A working knowledge of how to ensure that stock levels are maintained to meet demand



10 Supply pharmaceutical stock
















10.8 A working knowledge of the different forms of medicines and why it is important to supply appropriate quantities of the correct formulation and strength

10.9 A working knowledge of the difference between proprietary and generic medicines

10.10 A working knowledge of the action to be taken if stock is not fit for purpose


10.11 A working knowledge of the importance of checking stock for supply against current drug alerts/recalls

10.12 A working knowledge of the procedures for responding to urgent requests

10.13 A working knowledge of the importance of storing products correctly especially in relation to maintaining the cold chain the

10.14 A working knowledge of which products need special packaging and transportation and why it is important to adhere to these special requirements

10.15 A working knowledge of the importance of correctly labelling packages for delivery

10.16 A working knowledge of how automation is used to control stock

10.17 A working knowledge of how to supply stock to the correct destination using the correct delivery method



11 Manufacture and assemble medicinal products


To demonstrate knowledge and Name of document and unit/module number Accreditation team use only


understanding in this NOS, assistants should be able to apply:


Provider’s commentaryPlease type your commentary hereXX (expand as necessary)

Accreditation team’s commentaryPlease type your commentary hereXX (expand as necessary)








11.8 A working knowledge of the principles of good manufacturing practice, including pharmaceutical quality systems and your role within that

11.9 A working knowledge of the difference between preparation for individual patients and preparation for stock and how this is generally implemented in the workplace

11.10 A working knowledge of guidelines relating to manufacture of medicinal products

11.11 A working knowledge of the importance of using approved documentation

11.12 A working knowledge of the importance of maintaining a clean working environment

11.13 A working knowledge of personal hygiene and the use of protective / clean room clothing

11.14 A working knowledge of the possible sources of contamination and the appropriate methods of prevention

11.15 A working knowledge of the importance of environmental parameters, how to carry out their monitoring and the referral procedures if they are outside the set limits

11.16 A working knowledge of the chemical and physical properties of ingredients relevant to formulation and compounding, including any interactions between raw materials and components

11.17 A working knowledge of the principles of formulae calculations, weights and measures

11.18 A working knowledge of the preparation, assembly and maintenance of equipment


11.19 A working knowledge of the principles, properties and uses of different types of containers and when to use the various types

11.20 A working knowledge of the nature and use of different product forms

11.21 A working knowledge of the preparation and use of environmentally controlled conditions

11.22 A working knowledge of the principles and procedures for preparing medicinal products

11.23 A working knowledge of the reconciliation of materials, labelling and packaging requirements

11.24 A working knowledge of the reasons for safe systems of work including the quarantine requirements and the appropriate checking processes

11.25 A working knowledge of the how to identify near misses and errors

11.26 A working knowledge of the causes and consequences of near misses and errors

11.27 A working knowledge of the local and/or national error reporting procedures and communication channels

11.28 A working knowledge of the principles and procedures for the sterilisation of products

11.29 A working knowledge of the safe disposal of waste materials and cleaning materials

11.30 A working knowledge of how to dismantle, clean, decontaminate and store equipment correctly

11.31 A working knowledge of how to clean and decontaminate the preparation area

11.32 A working knowledge of the importance of recording, storing and retrieving information


in accordance with organisational procedures

12 Prepare Documentation and Materials for the Manufacture and Assembly of Medicinal Products
















12.10 A working knowledge of the recognised guidelines relating to manufacture of medicinal products


12.12 A working knowledge of the importance of personal hygiene and the correct use of protective / clean room clothing


12.13 A working knowledge of the different types of environmental areas and when they should be used

12.14 A working knowledge of the possible sources of contamination and appropriate methods of prevention



12.17 A working knowledge of the various types of products

12.18 A working knowledge of chemical and physical properties of ingredients relevant to formulation and compounding, including any interactions between raw materials and components

12.19 A working knowledge of the materials, consumables and equipment necessary for the preparation of medicinal products and the processes to minimise any associated risks

12.20 A working knowledge of labelling and packaging requirements and conventions

12.21 A working knowledge of the procedures for cleaning, decontamination, and preparing the environment and equipment


12.23 A working knowledge of how to identify near misses and errors



12.25 A working knowledge of the local and/or national error reporting procedures and communication channels


13 Prepare aseptic products









13.2 A working knowledge of the importance of working within the limits of your competence and authority, when to seek agreement or permission from others and when to refer on


to an appropriate person








13.10 A working knowledge of the recognised guidelines relating to aseptic preparation




13.13 A working knowledge of the different types of environmental areas and when they should be used

13.14 A working knowledge of the possible sources of contamination and the appropriate methods of prevention

13.15 A working knowledge of the importance of storing products correctly especially in relation to maintaining the cold chain from both chemical and microbiological aspects


13.17 A working knowledge of the chemical and physical properties of ingredients relevant to formulation and compounding, including any interactions between raw materials and components

13.18 A working knowledge of the different types of equipment and consumables and which products they must be used for

13.19 A working knowledge of the procedures for preparing, cleaning and decontaminating equipment and work areas

13.20 A working knowledge of the importance of storing equipment safely and in a condition ready for use


13.22 A working knowledge of the importance of environmental parameters, how to carry out their monitoring and the referral procedures


if they are outside the set limits

13.23 A working knowledge of aseptic techniques and when to use the different processes to minimise any associated risks

13.24 A working knowledge of the importance of carrying out accuracy and quality checks

13.25 A working knowledge of the importance of label and product reconciliation

13.26 A working knowledge of the reasons for safe systems of work including the quarantine requirements and the appropriate checking processes

13.27 A working knowledge of the methods and materials used for packaging

13.28 A working knowledge of the procedures for the safe handling and disposal of waste materials


13.30 A working knowledge of the how to identify near misses and errors


13.32 A working knowledge of local and/or national error reporting procedures and communication channels


14 Prepare documentation and


materials for the production of aseptic products
















14.10 A working knowledge of the recognised guidelines relating to aseptic preparation



14.13 A working knowledge of the different types of environmentally controlled areas and when they should be used

14.14 A working knowledge of the possible sources of contamination and appropriate methods of prevention

14.15 A working knowledge of the materials and equipment necessary for the preparation of aseptic production





14.19 A working knowledge of chemical and physical properties of ingredients relevant to formulation and compounding, including any interactions between raw materials and components

14.20 A working knowledge of the labelling and packaging requirements and conventions

14.21 A working knowledge of aseptic techniques and when to use the different processes to minimise any associated risks

14.22 A working knowledge of the procedures for cleaning, decontamination, and preparing the environment and components

14.23 A working knowledge of the importance of carrying out accuracy and quality checks


14.25 A working knowledge of how to identify near misses and errors


14.27 A working knowledge of local and/or national error reporting procedures and communication channels

14.28 A working knowledge of the importance of recording, storing and retrieving information


in accordance with organisational procedures

15 Assist in the issuing of prescribed items









15.4 A working knowledge of the legal, organisational and policy requirements relevant to your role, the role of others in your organisation and the activities being


carried out




15.8 A working knowledge of methods of enabling effective communication and supporting individuals to communicate their needs, views and preferences

15.9 A working knowledge of the current ethical and legal requirements that govern the issuing of a prescription

15.10 A working knowledge of the importance of confirming the individual's identity before issuing dispensed items

15.11 A working knowledge of the importance of providing relevant information on the prescribed item within your scope of practice

15.12 A working knowledge of how medicines are administered and how to safely store them

15.13 A working knowledge of the importance of ensuring that the appropriate packaging is used for issued medication



Assessment summary

Assessment method Pass mark Weighting

(Expand table as necessary)

Total 100%


Documentary evidence

List below the documentary evidence that you are providing

Please refer to the guidance notes on referencing documentary evidence provided on page 3

(expand table as necessary)

Submitting your accreditation documentation to the GPhC

You must send the following by post:

6 hard copies of your completed submission template (this document). NB. Supporting evidence is required electronically only, as outlined below

6 USB memory sticks each containing: - A Word and a .PDF version of your completed submission template - A .PDF version of each item of documentary evidence Quality Assurance (Education) team General Pharmaceutical Council 25 Canada Square London E14 5LQ

Delivery instructions: Please instruct the courier to deliver the documentation/package to the courier loading bay (deliveries will not be accepted at the main reception building)

Please ensure that the hard copies and electronic copies arrive with the GPhC’s Quality Assurance (Education) Team on, or before, the submission deadline. The deadline for submission of documentation is normally six weeks in advance of the accreditation visit; however, you will be notified of your exact deadline date when we confirm the date of your accreditation visit and pre-visit meeting.


Documents

MPharm template submission - pharmacyregulation.org · Web viewMCA, DA and/or combined programme(s) submission template - for events in the 2018-19 academic year 50. M