QUALITY SYSTEMSComparison , differences and summary

Prepared and presented by,“QUALITEAM”

Ankith DevunapalliDarshika Doshi

Harsh DharamshiSindhura Gaddamanugu

Srikanth Reddy Vattipalli

Qualiteam

ComparisonBased on:

Similarities in requirements for the various aspects of a quality system.

Only those requirements that are similar in more than 2 of the assigned documents included in this section

Qualiteam

Qualiteam

Management Responsibility• Establishment of quality system, quality policy, organization,

quality planning and resources (personnel and equipment)

• Review of the effectiveness and suitability of the quality system through reviews and audits.

Purchase Controls• Establishing procedures and documents for evaluation of

suppliers, verification of the purchased product and quality control of the purchase including establishment of quality system requirements, testing of the product, personnel training and responsibility communication.

Documentation Controls• Documentation control requirements are more or less the same

in all the regulation and guidances with minute differences.• Establishment, maintenance and control of all the

documentation required as per the regulation or guidance document.

• Establishment of procedures for document approval, distribution, implementation and finally document changes.

Qualiteam

Design Controls• Establishment and maintenance of procedures for

design and development planning, design inputs, design outputs, design verification and validation, review and records

Production & Process Controls• Production processes should be developed,

conducted, controlled and monitored to ensure a conforming product.

Corrective & Preventive action• Establishment of procedures and documentation

required for correction of non conforming products as well as prevention, includes prodcedures for identification of causes of non conformity, identification of actions to be taken, verification and validation of actions to be taken, dissemination of information and maintenance of records.

Qualiteam

Identification and traceability• Establishment of documented procedures

for the identification and distinction of the product throughout the entire life cycle

• Organization should establish and maintain documented procedures for traceability of the product whenever required.

Handling ,storage, distribution and installation.• Establishment of procedures for the

proper handling, storage, distribution and installation of the product to avoid mix ups, damage , contamination and to maintain its conformity

Differences:Despite the similarities these quality systems differ from each other in several aspects

Qualiteam

21 CFR 820

• Quality system requirements applicable

to manufactuting, packaging, labelling,

storage , installation and servicing of medical

devices

ISO 13485

• Quality system requirements fulfilled by the manufacturer of medical devices

• Process Approach

ICH Q10

• Quality System requirements for manufacture of pharmaceutical drug products, biotech and biological products

• Process approachCGMP for Combination Pdts.

•Guidance document for manufacturers of Combination pdts. as well as FDA

21 CFR 820• Not applicable

ISO 13485• Some clauses based

on ISO 9000

ICH Q10• Regional GMP, ICH

Q7 and ISO QMS

CGMP for Combination Pdts.

•Guidance document for manufacturers of Combination pdts. as well as FDA Qualiteam

21 CFR 820

• Highly Defined• Establishment of

quality policy,organization,resources and review of the system

ISO 13485

• Highly defined• Additionally

includes Mgmt commitment,customer focus, review input and output

ICH Q10

• Separate clause• Additionally includes:

mgmnt of outsourced activities, purchased goods, change in product ownershipCGMP for

Combination Pdts.

•Requirement as applicable to the type of product

21 CFR 820

ISO 13485

CGMP for Combination

Products

ICH Q10

• Not highly defined• Briefly mentioned in

Phamraceutical Quality Management sys.

•Highly Defined•Requirements as mentioned in Comparison

•Applicable as 21 CFR 820 for Medical Device as PMOA

21 CFR 820 & ISO 13485: 2003

• Includes requirements for establishment ,

maintenance, approval and distribution of all

relevant documentation

ICH Q10• No equivalent

clause

CGMP for Combination

Products

• Document control requirements a part of 21

CFR 820 and 21 CFR 210/211 (whichever

applicable)

21 CFR 820 &

ISO 13485:2003

• Highly defined

ICH Q10

• Not addressed specifically

• Management responsibility related to purchase highlighted

CGMP for Combination

Pdts.

• Not addressed specifically

Qualiteam

21 CFR 820 & CGMP

combination products

ISO 13485:200

3

Q 01

•Included as a separate clause•Specific information regarding buildings, equipments and environment contamination control, manufacturing materials process validation automated processes control of inspection

•Not included as a separate clause but included under resource management and product realization •No information regarding automated processes is provided

•It is not included as a separate clause but some information provided under resourse management•No special requirements mentioned when compared to QSR and ISO

Qualiteam

21 CFR 820 & CGMP

combination products

ISO 13485:200

3

Q 01

•Included as a separate clause.•Information regarding Record Retention, device master records and device history records and complaint file is provided•General information regarding control

of records is addressed under the clause documentation requirements.•DMR and DHR are not provided.•Feedback system in place of complaint files

•No Q10 equivalent

Qualiteam

21 CFR 820, ISO 13845:2003, CGMP for combination products

• Establishment of techniques for identifying and accepting the conformity and effectiveness of the product.

ICH Q10

• Mentioned briefly under process performance and product quality control

Qualiteam

21 CFR 820, ISO 13845:2003, CGMP

for combination products

• Establishment of documented procedures for the identification, control and disposition of non conforming product and prevent their unintended use.

ICH Q10

• No special requirements• Their handling was

mentioned briefly under CAPA

Qualiteam

21 CFR 820, ISO 13845:2003, CGMP for combination products

• Establish and document procedures for avoiding any non conformity of a product and prevent their recurrence.

ICH Q10

• CAPA is not so elaborate. • No requirements for

verification, validation and management review

Qualiteam

21 CFR 820, CGMP for

combination products

• Establishment of documented procedures for labeling of the product.

• Maintain and control procedures for proper packaging of the product to avoid damage during product release

ICH Q10, ISO 13845:2003

• No special requirements

Qualiteam

21 CFR 820 and CGMP

combination products

ISO 13485:2003

Q10No special requirements are mentioned

• Identification is same as that of 21 CFR 820•Manufacturer should identify and distinguish returned medical devices from conforming products

Manufacturer should establish and maintain procedures to identify the product throughout its entire lifecycle to avoid mixups.

Qualiteam

21 CFR 820 & CGMP combination

products

ISO 13485:200

3

Q10

•It is described in detail •Manufacturer should establish, maintain and document procedures to ensure proper handling, storage,Distribution and installation of the product to avoid mix-ups , damage ,contamination and adverse effects.

There is no special requirements

It is not described in detail when compared to QSR

Qualiteam

21 CFR 820 & CGMP combination

products

ISO 13485:2003

ICH Q10 There is no special requirements

•It is similar to 21 CFR •Particular requirement for active implantable medical devices and implantable medical devices is needed

organization should establish and maintain records of traceability of medical devices which may cause a potential risk to the user. Requirements concerned with receiving in process and finished device acceptance and servicing.

Qualiteam

Additional requirements in Q10Certain requirements were found exclusively in Q10.

Emphasis was made on quality risk managementknowledge management management of change in product ownership. Each and every clause specified special requirements at

different stages of product life cycle.

Qualiteam

SUMMARY:21 CFR 820, ISO 13845:2003 and CGMP show similarities in

documentation control ,design control management responsibilities , corrective and preventive actions and nonconforming products.

21 CFR 820 and ISO 13845:2003 mention similar requirements under purchase controls with CGMP’S showing the same with respect to medical devices. Labeling and packaging control is another clause where 21 CFR 820 and CGMP’S show similar requirements.

CGMP for combination products ,ISO 13485:2003 and 21 CFR 820 also mention the same requirements for handing, storage, distribution and installation.

Qualiteam

The differences are listed below:

21 CFR 820: no requirements for planning, internal communication, product realization and its planning and absence of special requirements for sterile medical devices and customer related processes.

ISO 13845:2003 : mentioned additional requirements under management responsibility which include management commitment, customer focus, review output and input, no requirements with respect to DMF, automated process, distribution, labeling and packaging.

ICH Q10: no special requirements for documentation control, identification and traceability , labeling

and packaging., handling ,storage, distribution and installation in Q10. Non conforming products were not given special requirements under Q10. Their handling was mentioned under corrective and preventive actions. Also there was no mention of verification and validation and management review under corrective and preventive actions in Q10. Purchase controls were not highly defined.

Certain requirements were found exclusively in Q10. Emphasis was made on quality risk management, knowledge management and management of change in product ownership. Each and every clause specified special requirements at different stages of product life cycle.

CGMP for combination products : when regulated by 21 CFR 820 ,additional requirements as per 21 CFR 210 and 211 which include drug product inspection , expiration dating , testing and release for distribution ,stability testing , reserve samples and testing and approval or rejection of components , drug product containers and closure are considered .

When regulated by 21 CFR 210 and 211 , additional requirements like design controls , purchasing controls, corrective and preventive actions are considered

Qualiteam