Essential Documentation

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ESSENTIAL

DOCUMENTATION


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Essential Documentation

Objectives

To review specific requirements for

essential document.

To list other types of GMP documents.

GMP rules on documents.

Documents are historical records of how

we practice GMP in pharmaceutical factory.


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PURPOSE OF DOCUMENTATION:Essential statutory requirement

To be clear of what is to be done

To keep records of what has been done

To provide audit trials for complaint

investigation.

To help us decide and take corrective actionin case of quality problem.


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DOCUMENTATION LEVELS :

The hierarchy of documents is defined

in

Category1

Category2

Category3


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Category1:The document which are the apex

documents of the pyramid, based on which

the other documents shall be prepared.The category 1 documents include:

Site Master File [SMF].

Quality Manual [QM].

Training Programes [TP] .

Validation Master Plan [VMP].


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Category2:The documents which are prepared for the

actual execution of the activity.

Standard Operating Procedures [SOPs].

Protocols.

Qualification Documents.

Master Formula Records.

Batch Manufacturing & Packing Records.

Specifications and method of analysis


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Category3:

The documents which are the recording

formats.

The category 3 documents includes

Formats & Reports.

Logbooks.,

Technology transfer records


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Essential DocumentationBASIC DOCUMENTSProduction Related:

Batch Manufacturing records (BMR)

Batch packaging records (BPR)

These are der ived from: -

Master formulae records (MFR)

To operate equipment and processes we need-

Standard operating procedure (SOP).


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Essential DocumentationBASIC DOCUMENTS

Quality Control Related:

Material specifications.

Product specifications.

Analytical method & procedures.

Calibration procedures for instrument.Operating procedures for instrument.

Microbiological procedures.


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OTHER DOCUMENTS:

Housekeeping & sanitation logs.

Equipment & instrument logs.

Validation documents.

Annual product reviews.

Maintenance & machine history card.

Complaint records.

Training records.


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Essential DocumentationPRODUCTION DOCUMENTS:

MFR: is essentially a specific guide detailingmanufacturing and packaging process for aproduct. It includes instructions on inprocess

controls and sampling during the productionprocess. Usually prepared by R & D or ParentCompany.

BMR/BPR: is an extract from the MFR whichgives stepwise instruction on how to process aproduct. It includes tables and blank spaces tobe filled in with observations as the product is

processed in the factory.


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Essential DocumentationBMR INCLUDES AT LEAST THE FOLLOWING

DATA:

Product name/batch number/batch size/lot sizetheoretical & expected yields.

Actual quantities of each raw material issued andchecked.

Step wise processing data with time/signature ofresponsible person for each operations.

Key equipment used in the process.Area clearance/equipment cleanliness checks.

Environmental checks (temperature/humidity)

Inprocess checks.


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Essential DocumentationBPR INCLUDES AT LEAST THE FOLLOWINGDATA

:Product name/batch number/pack size/quantitypacked.

Label type and overprinting details approval

(specimen).Reconciliation of materials used in packaging.

Issue/ return of material to store.

Details of packing operation with time/ signature of

responsible person for each operation.Inprocess controls (volume/ weight/ quantity percontainer)

Line clearance.

Outer pack and shipper packing details.


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Standard Operating Procedures

WHAT IS AN SOP?

These are written and authorized guidelineswhich describe / tell how to perform certain

activities. It defines scope and responsibility of

both operator and officer, carrying out these

activities. It also warns of consequences of failureto follow the guidelines


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Standard Operating Procedures:

Who should prepare?

Expert/experienced person knowing theoperation.

Who should check?

Department head or manager

Who should approve?

Q A or designated person

Where should the SOP be stored?Original with QA

Controlled copy with department

Display copy displayed at the work place.



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Standard Operating ProceduresActivities which require SOPs?

Receipt of all material deliveries

Internal labelling, quarantine and storage ofmaterials

Operation, maintenance and cleaning of all

instruments and equipment

Sampling of materials

Batch numbering systems

Material testing at all stages of production



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Standard Operating ProceduresActivities which requi re SOPs?

Batch release or rejection.

Storage and distribution procedures.Equipment assembly and validation

Calibration and operation of analytical apparatus

Maintenance, cleaning and sanitation procedure.

Personnel recruitment, training,

clothing and hygiene

Environmental monitoring


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Essential DocumentationPROTOCOLS:

These are also procedures to perform validation

activities.

A protocol may include formats/ tables for

filling information during the validation activity.

Alternatively the protocol may indicate

preparation of reports in other standard

formats available for the validation activity.


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Essential DocumentationQUAL ITY CONTROL DOCUMENTS:

Material & product specifications

List of test to be done with acceptance limits for

compliance

Analytical methods & procedure :Detailed instruction on analytical test procedures

Same test procedures may have pharmacoepial

references.Calibration procedures for instrument

Detailed test to be performed to ensure correct

calibration status.


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Essential DocumentationQUALITY CONTROL DOCUMENTS:

Microbiological procedures

Sterility testing method

Bio assay proceduresTotal viable count and microbial limit test

procedure.


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Essential DocumentationOTHER RELATED DOCUMENTS:Log books:

Required for each equipment/ instrument to

enumerate what product was processed or

tested.

Idle time and cleaning time details.

Specific break down and repair entries.

X- check entries in BMR/BPR etc.


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Essential DocumentationVALIDATION DOCUMENTS:

Equipment qualification

URS/DQ/IQ/OQ/PQ

Process validation

Cleaning validation

Aseptic media fill validation

Analytical method validation.


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Essential DocumentationANNUAL PRODUCT REVI EW:

Key record to check on-going product

performance batch wise details of product yields

and key quality parameters.

MAINTENANCE & MACHINE HISTORYCARDS:

List of periodic preventive maintenance, major

repairs carried out on each machine.

Setup and modification on machine operation.


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Essential DocumentationCOMPLIANT RECORDS:Details of market complaints received.

Investigation and findings and process

improvements.TRAINI NG RECORDS:

Individual training of pharmacist/ chemist/stores and maintenance persons

GMPwater / air systems / shopflooractivitiesworkmen training on hygiene &gowning.


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STOCK CONTROL DOCUMENTS:

Responsibility of stores:

Receipt, Issues in stock registers/ computers

The records include batch numbers, status,

quantities and expiry date

Required for:

Production planning

Purchasing activity

Ensuring orderly usage of material FIFO to

EEFO.



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DISTRIBUTION RECORDSFor distribution, there should be one recordper batch of product. It should contain the

batch number, quantity and destination ofeach delivery.

Why are these records important?

In the case of a product recall, theinformation on distribution can be obtainedrapidly from a single source.


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REVIEW OF DOCUMENTATION:

Specifications and SOPs.

Done by concerned department at periodic

intervals12/24 months

OR

After any significant change is made.Product BMR/BPR are reviewed by QA prior

to each batch release.



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Documentation & Control Storage / Destruction

Retrieval

Distribution

Training

Authorization

Approval

Review

Prepare

Design

Good documentation

systems


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Essential DocumentationOther documentation:

Labels are also part of documentation

Internal labelsstatus/ identity

External labelproduct labels

LABELS:IDENTITY:

Placed on containers, vessels, equipment toIDENTIFY the MATERIAL that is inside.

STATUS:

Placed on containers, vessels and equipment toindicate CURRENT STATUS of MATERIAL that isinside


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Documentation & Control

LabelsWhat must be labelled?

What must be on the label?

Who has responsibility for labelling?

The identification affixed to the recipients,

equipment, and facilities and on products

should be clear, without ambiguities.

Different colors indicating its conditions

might be used (e.g.: in quarantine,

approved, rejected, clean).


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Finished Product Label

NameActive ingredients and amounts

Batch number

Expiry date

Storage conditions

Precautions if necessary

Directions for useEarnings

Name and address of manufacturer

The approved master of a

label need not to be a label

itself but may consist of a

approved set of relevant

data used by or sent to a

label printer. A 0-copy of the

label may be filled together

with the batch record as

proof of compliance of the

master.

Reference 19


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Rules About Making Records

Always make record, or enter signature etcwhen (or immediately after) the action or

reading has been taken, or the check has

been made.Records should always be made as things

happen. NOT at the end of the shift, day or

week they are about current events, nothistory.


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A person entering a second check signature or

initials is confirming that he or she actuallysaw what was done (for example, a weighing)and has personally checked that everythingwas correct (product, material, batch, quantity,reading or whatever).

It is NOT good enough, and it could be verydangerous, to just trust your mate to have got

it right, and write in second checkinitials/signatures at the end of the day. These,too should be entered as things happen, whenthey have been seen to happen.


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Records should always be NEAT andCLEAR. They do not have to be beautiful, butremember, other may need to read them infive or more years time.

If you make a mistake when making an entryon a document. It is not a crime. But if you domake a mistake, do not obliterate it or cover it

up, cross it out neatly (so that it can still beread), make the correction and sign/initial andadd the date (with any explanation necessary)

Essential Documentation

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