The document outlines Good Manufacturing Practices (GMP) for the documentation of Active Pharmaceutical Ingredients (APIs). It emphasizes the necessity of maintaining accurate records and details various types of documents required, such as batch production records, lab control records, and master production instructions. The guidance stresses the importance of proper documentation practices to ensure product quality and compliance with regulatory standards.

1. ICH Q7AICH Q7A
GMP GuIdAnCe ForGMP GuIdAnCe For
APIAPI
GoodGood
documentadocumenta
tiontion
PracticesPractices

2. WhyWhy
documentation isdocumentation is
required..?required..?
 To define the method and controlTo define the method and control
 To prevent errors from spokenTo prevent errors from spoken
communicationcommunication
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3. this sectionthis section
coverscovers
 Documentation System andDocumentation System and
SpecificationsSpecifications
 Equipment Cleaning and Use RecordEquipment Cleaning and Use Record
 Records of Raw Materials,Records of Raw Materials,
Intermediates, API Labeling andIntermediates, API Labeling and
Packaging MaterialsPackaging Materials
 Master Production InstructionsMaster Production Instructions
 Batch Production Records (BPR)Batch Production Records (BPR)
 Laboratory Control RecordsLaboratory Control Records
 Batch Record ReviewBatch Record Review

4. Good
documentation
“Good Documentation” can
achieve by continuous practice,
like habit.

5. documentatidocumentati
on andon and
recordsrecords
What isWhat is
Document?Document?
What is Record?What is Record?

6. documentatidocumentati
on andon and
recordsrecords
Document:Document:
 Document provides a guidance / directionDocument provides a guidance / direction
for performing work, making decisionfor performing work, making decision
which effects the quality of the product.which effects the quality of the product.
Ex: SOP’s, Spec & MOA, protocols ……etc.Ex: SOP’s, Spec & MOA, protocols ……etc.
Record:Record:
 Record is evidence that a quality systemRecord is evidence that a quality system
action is performedaction is performed
Ex: Registers, records, reports…..etc.Ex: Registers, records, reports…..etc.

7. documentatidocumentati
on andon and
recordsrecords
This section covers a large amount of
guidance. Most of it is NOT NEW…..
Basic Requirements for documentationBasic Requirements for documentation
 All the documents should be numbered forAll the documents should be numbered for
traceabilitytraceability
 Reproduced document should be clear &Reproduced document should be clear &
legiblelegible
 As soon as a document is superseded, theAs soon as a document is superseded, the
copies of the earlier version must be retrievecopies of the earlier version must be retrieve
and destroyedand destroyed

8. 6.1 doc’ system6.1 doc’ system
andand
sPecificationssPecifications
 Review, approval and distributionReview, approval and distribution
of documentsof documents
 Revision historyRevision history
 Record retentionRecord retention
Just what is needed for a document ?

9. 6.1 doc’ system6.1 doc’ system
andand
sPecificationssPecifications
All documents related to the manufacture of
intermediates or APIs should be prepared,
reviewed, approved and distributed according to
written procedures
 Review, approval and distribution ofReview, approval and distribution of
documentsdocuments

10.  If any changes were made in theIf any changes were made in the
approved document, we shouldapproved document, we should
have the revision history to tracehave the revision history to trace
out the changes made in theout the changes made in the
previous document.previous document.
Revision History
6.1 doc’ system6.1 doc’ system
andand
sPecificationssPecifications

11.  Of production, control and distributionOf production, control and distribution
recordsrecords
 At least 1 year after expiry dateAt least 1 year after expiry date
 For APIs with retest date - at least 3For APIs with retest date - at least 3
years after complete distribution of theyears after complete distribution of the
batchbatch
Record retention
6.1 Doc’ SyStem6.1 Doc’ SyStem
anDanD
SpecificationSSpecificationS

12. Documents to be stored for life time
 Technology transfer documentTechnology transfer document
 DMFDMF
 Validations (Process & method)/QualificationsValidations (Process & method)/Qualifications
 Impurity profileImpurity profile
 Degradation studiesDegradation studies
 Stress studiesStress studies
 Stability dataStability data
 Product specificationsProduct specifications
 BPR’s submitted in DMF’sBPR’s submitted in DMF’s
 Annual review reportsAnnual review reports
 ComplaintsComplaints
 Vendor qualification documentsVendor qualification documents
 Obsolete documentsObsolete documents
 Training records……etcTraining records……etc
6.1 Doc’ SyStem anD6.1 Doc’ SyStem anD
SpecificationSSpecificationS

13.  Records may be retained as originals orRecords may be retained as originals or
true copies (accurate reproductions)true copies (accurate reproductions)
 Originals or copies should be availableOriginals or copies should be available
at the establishment where the activityat the establishment where the activity
occurredoccurred
 Prompt retrieval from another locationPrompt retrieval from another location
by electronic or other means isby electronic or other means is
acceptableacceptable
Record retention
6.1 Doc’ SyStem6.1 Doc’ SyStem
anDanD
SpecificationSSpecificationS

14. 6.1 Doc’ SyStem6.1 Doc’ SyStem
anDanD
SpecificationSSpecificationS
 If reduction techniques (microfilm) orIf reduction techniques (microfilm) or
electronic records are used, suitableelectronic records are used, suitable
retrieval equipment and means toretrieval equipment and means to
produce hard copy should be readilyproduce hard copy should be readily
availableavailable
Record retention……cont.

15. Entries in records should
•Use proper units of measure( ºC, Kg, Lt…etc)
•Be indelible (incapable of being removed,
erased or washed away)
•Made in spaces provided
•Made directly after performing the activity
•Use blue / Black bal pen only.
•Post it notes scrap pieces of papers are not to
be used for recording data.
Ditto marks and arrows are not acceptable
6.1 Doc’ SyStem6.1 Doc’ SyStem
anDanD
SpecificationSSpecificationS

16.  It shall be the responsibility of the personnel making use of the
documents to see that the documents are maintained properly
without being subject to any sort of damage
 If an entire page or section or a cell is intended to be left blank in
the BPR, Work books, Logbooks, Equipment log books, Inward
registers and other reports a diagonal line is to be placed through
the page or section or cell and written ‘NA’ with signature & date
 All the entries shall be made as and when the operation is being
completed
 Use of ear brackets with one signature & date to indicate
verification of several operations can be done
 In the batch production records and inward registers, date
column need not be filled each and every time. Writing the date
in first row of each and every page is adequate. In addition,
whenever the date changes at 00.00 hours the first entry shall
also have the new date entered.
Entries in records should……

17. Corrections
Note: All corrections arising based on review of the
document to be done with current date only
 Overwriting or erasing or blocking of dataOverwriting or erasing or blocking of data
shall not be doneshall not be done
 Errors and overwriting shall be corrected withErrors and overwriting shall be corrected with
a single line cross out, then initialled anda single line cross out, then initialled and
dateddated
 Correction fluids shall never be usedCorrection fluids shall never be used
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18.  AuthenticatedAuthenticated
 SecureSecure
Electronic signatures (if used) should be
6.1 Doc’ SyStem6.1 Doc’ SyStem
anDanD
SpecificationSSpecificationS

19. 6.2 equip6.2 equip
cleaning anDcleaning anD
uSe RecoRDuSe RecoRD
 Records of major equipmentRecords of major equipment
– useuse
– cleaningcleaning
– sanitization and/or sterilization (ifsanitization and/or sterilization (if
performed)performed)
– maintenancemaintenance

20. equip cleaningequip cleaning
anD uSe RecoRD . .anD uSe RecoRD . .
..
 Should includeShould include
– Date (DD/MM/YY or DD-MM-YY)Date (DD/MM/YY or DD-MM-YY)
Note: Effective date can written asNote: Effective date can written as
DD-MM-YYYY Ex: 27-04-2009DD-MM-YYYY Ex: 27-04-2009
– Time ( in 24 hrs pattern, if appropriate)Time ( in 24 hrs pattern, if appropriate)
– ProductProduct
– Batch numberBatch number
– Person performing cleaning andPerson performing cleaning and
maintenance & reviewer signature.maintenance & reviewer signature.

21. Equip ClEaningEquip ClEaning
and usE RECoRd . .and usE RECoRd . .
..
 Records of cleaning, maintenance andRecords of cleaning, maintenance and
use can be part of batch record oruse can be part of batch record or
maintained separatelymaintained separately
Dedicated equipment

22. 6.3 RECoRds of6.3 RECoRds of
MatERialsMatERials
 Name of manufacturerName of manufacturer
 Identity and quantity of eachIdentity and quantity of each
shipment of each batchshipment of each batch
 Date of receiptDate of receipt
 Batch No.Batch No.
For raw materials, intermediates, API packaging
and labeling

23. ClaRifiCationClaRifiCation
of tERMsof tERMs
 Master Production InstructionMaster Production Instruction
– master recipe or SOPmaster recipe or SOP
 Batch Production RecordBatch Production Record
– record of actual batch producedrecord of actual batch produced

24. 6.4 MastER foRMulaE6.4 MastER foRMulaE
 Name of intermediate or API being manufacturedName of intermediate or API being manufactured
 Identifying document reference codeIdentifying document reference code
 The procedure shall start with general instruction.The procedure shall start with general instruction.
 Synthetic scheme and process flow along withSynthetic scheme and process flow along with
equipment details.equipment details.
 Holding time study for wet/ dry materialHolding time study for wet/ dry material
 Complete list of raw materials and intermediatesComplete list of raw materials and intermediates
 Accurate statement of the quantity or ratio of eachAccurate statement of the quantity or ratio of each
material to be used (including unit of measure)material to be used (including unit of measure)
 Major production equipment to be usedMajor production equipment to be used
 Special notations or precautionsSpecial notations or precautions
 The conditions in which API/ Intermediate shall beThe conditions in which API/ Intermediate shall be
stored, type of packing materials used and thestored, type of packing materials used and the
labelling .labelling .

25.  Sequences to be followedSequences to be followed
 Ranges of process parametersRanges of process parameters
 Sampling instructionsSampling instructions
 In-process controls with acceptance criteriaIn-process controls with acceptance criteria
 Time limitsTime limits
 Expected yieldExpected yield
Note: The finished product label should beNote: The finished product label should be
attached with the master formulaeattached with the master formulae
Detailed production instructions
6.4 MastER foRMulaE6.4 MastER foRMulaE

26. 6.5 BatCh6.5 BatCh
pRoduCtionpRoduCtion
RECoRdsRECoRds
 Should be prepared for eachShould be prepared for each
intermediate and APIintermediate and API
 Should include complete informationShould include complete information
relating to production and control ofrelating to production and control of
the batchthe batch

27. 6.5 BatCh6.5 BatCh
pRoduCtionpRoduCtion
RECoRdsRECoRds
 Checked that it is the correct versionChecked that it is the correct version
and a legible accurate reproduction ofand a legible accurate reproduction of
the masterthe master
 Numbered with a unique batch or idNumbered with a unique batch or id
number, dated and signednumber, dated and signed
Prior to issuing for use

28. 6.5 BatCh6.5 BatCh
pRoduCtionpRoduCtion
RECoRdsRECoRds
Documentation of completion of each
significant step should include
 DatesDates
 Times when appropriateTimes when appropriate
 Identity of major equipmentIdentity of major equipment
 Specific information for each material usedSpecific information for each material used
– weights or amountweights or amount
– batch or id numberbatch or id number
Note that in continuous production,
the product code, date and time can
serve as the unique identifier until
final number is allocated

29. 6.5 BatCh6.5 BatCh
pRoduCtionpRoduCtion
RECoRdsRECoRds
 Any deviation / Incident notedAny deviation / Incident noted
 In-process or lab test resultsIn-process or lab test results
 Actual yieldActual yield
 Description of packagingDescription of packaging
 Representative label (Representative label (Ex: Blending BPREx: Blending BPR))
Documentation of completion of each
significant step should include

30. 6.5 BatCh6.5 BatCh
pRoduCtionpRoduCtion
RECoRdsRECoRds
 Investigation (if appropriate)Investigation (if appropriate)
– critical deviations should becritical deviations should be
investigatedinvestigated
– investigation should extend to otherinvestigation should extend to other
batches that may be associatedbatches that may be associated
 Results of release testingResults of release testing
Documentation of completion of each
significant step should include

31. 6.6 Lab ControL6.6 Lab ControL
reCordsreCords
 Complete data from all tests conductedComplete data from all tests conducted
 Description of sampleDescription of sample
– material name or sourcematerial name or source
– batch number or other distinctive codebatch number or other distinctive code
– date takendate taken
– quantity and date received for testingquantity and date received for testing
(where appropriate)(where appropriate)
 Reference to test method usedReference to test method used
 Weight or measure of sample usedWeight or measure of sample used

32. 6.6 Lab ControL6.6 Lab ControL
reCordsreCords
 Data on preparation and testing ofData on preparation and testing of
– reference standardsreference standards
– reagentsreagents
– standard solutionsstandard solutions
 Complete record of raw data generatedComplete record of raw data generated
in addition to graphs, charts, andin addition to graphs, charts, and
spectra (Chromatograms).spectra (Chromatograms).
 Record of calculations includingRecord of calculations including
– units of measureunits of measure
– conversion factorsconversion factors
– equivalency factorsequivalency factors

33. 6.6 Lab ControL6.6 Lab ControL
reCordsreCords
 Statement of test results andStatement of test results and
comparison with acceptance criteriacomparison with acceptance criteria
 Signature of person who performedSignature of person who performed
each testeach test
 Date the test was performedDate the test was performed
 Date and signature of person reviewingDate and signature of person reviewing
forfor
– accuracyaccuracy
– completenesscompleteness
– compliance with established standardscompliance with established standards

34. CompLete LabCompLete Lab
reCordsreCords
 Any modification to an analyticalAny modification to an analytical
method shall be followed as per changemethod shall be followed as per change
control procedure.control procedure.
 Calibration of lab instrumentsCalibration of lab instruments
 Stability testing on APIsStability testing on APIs
 Out of specification (OOS)Out of specification (OOS)
investigationsinvestigations

35. CompLete LabCompLete Lab
reCordsreCords
 Review of batch production record and labReview of batch production record and lab
control records before batch is released orcontrol records before batch is released or
distributeddistributed
– according to written procedureaccording to written procedure
– any deviations, investigations or OOS shouldany deviations, investigations or OOS should
be included in this reviewbe included in this review
non-critical process steps also to benon-critical process steps also to be
– reviewed by qualified production personnelreviewed by qualified production personnel
– following procedures approved by qualityfollowing procedures approved by quality
assurance and the investigation details to beassurance and the investigation details to be
documented.documented.

36. reLeasereLease
authorityauthority
 Quality Assurance is responsible forQuality Assurance is responsible for
releasing or rejecting all APIs (2.2)releasing or rejecting all APIs (2.2)
Records to be maintained:Records to be maintained:
 Packing records.Packing records.
 Dispatch RecordsDispatch Records
 Customer specifications & MOA….etcCustomer specifications & MOA….etc

37. any
doubts
…..?