015 GMP Documentation1

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General Aspects and Requirements

Types of GMP Documentation Purposes of GMP Documentation The Structure of Document Management

Evaluation of the Documentation System The Document Management Cycle


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GMP documentation is one critical aspectof our business and it is a legalrequirement too!

Inspection or audit observations frequentlyidentify outdated documents, inadequate

version control, and poor documentationpractices

As the Quality Unit is responsible for


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GMP Documentation can be defined as:

Any procedure, instruction, logbook,record, raw data, manual, or policyassociated with the development,manufacture, testing, marketing, anddistribution of a medicinal product required

to demonstrate compliance with the GMPsand other regulatory requirements Or more shortly:

A GMP document is any written record


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The site Quality Manager is responsible forensuring that:

the systems to manage and control GMPdocumentation are available and complywith GMP requirements

all GMP documents in the documentationmanagement system are in compliancewith the regulatory files and GMPrequirements.

The site functional Information Solution


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Each site or facility handling GMPdocumentation must have systems andprocedures for their management and

control.

These systems and procedures must becompliant with company policies and GMPrequirements.

Documentation sub ect to com an


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All important information that is generated during anoperation or process must be recorded together withwho performed the operation and when it was carriedout.

Such information should be legible, accurate, dated,traceable, and accessible.

This information should reflect the complete history ofthe manufacture, packaging and control of the product.


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Careful design of documents should make them easy toread, easy to understand and easy to complete properly

Original documents should be easily distinguishable fromphotocopies, and should have clear and conciseinformation

Good documents should have sufficient space forentries, to record variable information and signature andto attach print-outs etc. Unused empty fields should becrossed-out.


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GMP documentation must clearly state titleand content and must possess a siteunique identifying number

GMP documentation must be formallyapproved, issued and version controlled

Data entries must be made or completedat the time the action is performed


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Master documents must be subject toappropriate controls to ensure that onlyone version is current. Such documents

must be approved, signed and dated

Modifications to master documents mustbe managed through change control

There must be a periodic review of GMPdocuments to ensure that the are


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All information contained within GMPdocumentation that is stored and maintainedelectronically must be made available in both

electronic and human readable formats

All SA product and system related documentsare considered the intellectual property of SAand must be maintained and distributed in aconfidential manner.


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This Documentation includes, but isnot limited to the following Batch

Related Records: Master Batch Records (e.g. Processing

Instructions,

(Packaging Instructions) Batch Records (e.g. Batch Production

Records)

Raw Data Records


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Non Batch related Records Qualification and Validation Documents

Change Control Documentation Engineering Drawings Maintenance and Calibration Records

Complaint Records Recalls and Returns Environmental Monitoring Records Utility Monitoring Records


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Non Batch related Records(continued):

Personnel Training Records Quality Agreements (i.e. TechnicalAgreements)

Failure Investigation and ReportingRecords

Cleaning and Sanitization Records

Entry Records for Controlled Areas


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Some other examples of documentation that

must not be forgotten: SOP Annexes

Computer files Process Flow and other Diagrams (e.g. gowning

diagrams)

Raw Data Sheets (charts, chromatograms, etc.)

Technical Reports

Labels (room and equipment status, sampling, materialstatus)


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There are three main purposes for GMPdocumentation:

To meet legal requirements including allGMP expectations

To meet our business requirements To form the basis of good scientific

decision making


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To understand what needs to be done (theprocess)

To understand how to do it (the method) To understand why it needs to be done

(the context) To understand who must do it (the

responsibility) To understand when to do it (frequency,

close out


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If you cannot answer all of the questionsfrom the previous slide, then thedocumentation (system) has somehow

failed

Remember, documentation should equally

be for our own benefit as it is for theregulators

And: ins ections normall rovide ood


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PROCEDURES SHOULD BE WRITTEN ANDFOLLOWED

It is a concern if an SOP has not been in place

But it is a violation of the GMP requirements, ifthe SOP is present, but not followed.


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The regulators expect things tooccasionally go wrong during

manufacturing or testing

However, we must ensure that we clearly

document and sign off our decisions witha rationale behind

In reality, this is one area of a general


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There should be one umbrella document(SOP) that defines the management of

GMP documentation, our approach todocumentation

For example:

What type of documents are covered byGMP

What is raw data and what not

Who is responsible for each GMP


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It is important to have the most up to dateworking copy of a document issued to a

department. But how can we stopuncontrolled copies being photocopied(e.g. replacement page of BMR)

It is easier now for people to makeuncontrolled copies as they have generalaccess to photocopy machines.

Apart from rigorous training, many


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Document AdministrationDepartment

Centralized better than de-centralized? Reporting Relationship Must be audited like all other GMP related

departments

Document Numbering

S stem


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Require clear rules and procedures aboutarchiving of superseded documents

Defined Retention Periods No loss of Information during retention

(thermal printers) Fire and waterproof archives Access and Control of document archives Readily Retrievable (in case of compliant,

recall, audit)


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The retention period for all qualitydocumentation must meet legal and regulatory

requirements of all relevant markets.

It is the responsibility of each department toensure the control and retention of GMPDocuments in accordance with the systems andprocedures.


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We need to review whether our documentation system is workingcorrectly or not

It is easy to make general statements to the effect that: nobody fills out the documents correctly there are always problems with the documentation

the system does not work

As with any other process, we need to collect and analyse real datato see if there is a problem or not, or to identify whetherperformance is improving or not.

It is a well known phenomenon that improvements will occur just

because people know that we are measuring it.


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Some examples of what we canreview and evaluate:

% SOPs not reviewed within the requiredtime frame

% Batch Records with missing information

at review time % of logbooks not reviewed within the

correct time frame

% of uncontrolled technical drawings


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Written procedures need to be drafted in away that will help avoid errors:

clear instructions written in sufficient detail well understandable

version controlled written with a view for training defining the responsibilities

easy to implement.


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The document is only useful if the person whoshould use it, actually understands it

Therefore consider the following aspects whendrafting documents:

educational level

cultural background

linguistic ability comprehension ability

readability Index for average English:

13 words per sentence.


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What can be reviewed and evaluatedwhen checking individual documents?

the information that is stated the information that is not stated/missing steps scientifically incorrect information/requirements

conflicting requirements safety issues legal/regulatory issues the rationale for the document (is the document

servin a useful ur ose .


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GMP Documentation is normally signed bythe following persons:

Author: a knowledgeable and trained person in therelevant

topic within the relevant department (QA only authortheir own documents!)

Reviewer: who is someone equally proficient as theauthor

Approver: an appropriate level of management (normallythe

QA manager).


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Effective Version Control is an essential partof the GMP document management system

There must be a high level of confidencethat only the latest versions of documentsexist as working copies

There are two ways of dealing withsuperseded versions

The new document is issued and the


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New/Updated documents have beenwritten for a reason, and it is essential

that relevant people are informed/trainedas appropriate before the documentbecomes effective

The document can be trained on a one toone basis or within a group. Thedocument can be read by the relevant


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People can generally have different preferences in theirway of learning, but the most important thing is that thetime for training is built into the cycle, and properly

documented

The documentation system must ensure that absenteesare also trained upon their return to work

The system must also ensure that the proof of trainingcan be retrieved easily.


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The effective date of the document (e.g.SOPs, protocols) should permit enough

time for training of relevant personnel Procedures, once effective, should be as

working documents, and treated as such

The best procedure is of no value in thesupervisors locked office!

And then: Follow up and monitor!


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GMP Documentation is one critical aspectof our business.

All documentation required by GMPregulations must be issued, managed, andcontrolled by a document managementsystem.

QA have a major role to play in managingGMP documentation.

Inspections and audits regularly identify

issues with documentation system.


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Document management system

needs to be clear and logical Use a top down approach (QA must takethe lead!)

Use flow chart and other tools to definedocumentation needs Includes all types of documentation

(including electronic)


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