Batch Records

ARISTO , PRODUCTION ,DEPT

 Batch Records
Content of Module
1. Type and principle of document .
2. What is Batch Record?
3. What it comprises of?
4. Why Batch Record is Required?
5. Particulars to be shown in the Batch Record as
per Schedule U /TGA /MHRA / CFR
6. Flow chart of Batch Records
7. Preparation,Authorization ,issuance ,filling
retrieval,review,release,retain and disposal
procedure.
8. Encountered discrepancies
9. Case Study
 Type of Document
1.COMMITMENT TYPE DOCUMENT
Site Master File ,Company Quality Policy,
Company Quality Manual, Departmental
Manual.
2.DIRECTIVE/INSTRUCTIVE TYPE
DOCUMENTS
Activity plans & reviews
SOPS, STPS ,GPS ,Specs ,MFRS ,BMRS
3. RECORD/DATTA CONTROL TYPE
DOCUMENTS
Daily Records & Raw Data
4.OTHER TYPES
Photograph.Layout etc.
 WHAT IS DOCUMENTATION

Documentation is an essential part of

Quality System and relates to all aspects of
cGMP
 PRINCIPLES OF DOCUMENTATION
•General Principles – I
•Purpose of documentation:
•To Ensure that there are Specifications for All
Materials and Methods of Manufacture and
Control
•Ensure All Personnel Know What to Do,
How, Where and When to Do It
•Ensure That Authorised Persons Have All
Necessary Information
•Provide Audit Trail
•Ensures the Applicability of Current
Regulatory Issues
•Permits Tracing of Batch History
PRINCIPLES OF DOCUMENTATION

•General Principles – II
•Documents should be free from any errors
•Designed
•Prepared
•Reviewed
•Authorised
•Distributed
•Retrieved
•Archived
 PRINCIPLES OF DOCUMENTATION

•General Principles – III

• Inspectors looks for the “Style” of the document

•Instructions in the imperative

•Not long sentences or complex sentences

•Short sentences, easy to understand.
•No document should be changed without
authorization
•Approved, signed and dated by appropriate
authorized persons
 PRINCIPLES OF DOCUMENTATION

General Principles – IV

Distribution of documentation
Electronically or photographically recorded data
 PRINCIPLES OF DOCUMENTATION

General Principles – V

Review
system for regular revision

Completion
during the process
 Documentation Pyramid
ARISTO
QUALITY SITE MASTER PLAN
POLICY VALIDATION MASTER PLAN
QUALITY COMPUTER VALIDATION PLAN
SYSTEM
MANUAL
QUALITY
SYSTEM
PROCEDURES
BATCH
MASTER
DOCUMENTS

BATCH RECORDS
RAW DATA
 Batch Records
What is a Batch Record?
Batch Record is a set of manufacturing and packaging
procedures along with all relevant analytical records.

What it Comprises of?

Batch Record contains
1.Batch Manufacturing record
2.Batch Packing Record
3.Analytical Reports
4.Other releavented Records
n-process print,Graph,Specimen Sample etc.)
 Why Batch Records is Required?
• Batch Record contains Manufacturing procedures,
list of Equipment to be used for manufacturing.

• It is the only proof for the batches manufactured and

packed at the time of actual manufacturing.

• Batch Records provide the history of each batch of

the product and also of all other relevant information
pertinent to the quality of the product.
 Why Batch Records is Required?
• It is required for the root cause analysis when ever
there is a need for investigation .
• It is required to register the products in different
countries and regulatory authorities
•It is also a mandatory requirements of all regulatory bodies.
• It provides necessary information for trend analysis , retrospective
validations & Product Quality Review
• It helps to calculate the cost of production & standardization of
process time
• It provides all necessary instructions which helps to compliance
with the required standard
 REGULATORY REQUIREMENTS

Particulars to be shown in the Batch Record as

per Schedule U /TGA /MHRA ?
SCHEDULE - U
•Serial Number
•Name of the product
•Reference of Master Formula Record
•Lot/Batch size
•Lot/Batch number
•Date of commencement of manufacturing and completion

•Expiry date of product.

•Name of all ingredients ,specification, quantities required for the

lot/batch size and quantity actual used.
SCHEDULE - U

•Dispensing of material by responsible person and counter checked by

other competent technical person.

•Control number of material used in the formulation.

•Reference to analytical report number.

•Date time and duration of processing steps.

•Details of environmental controls like room temperature,relative

humidity,particle count ,microbial count etc.

•Theoretical weight and actual weight of in-processed material

SCHEDULE - U
•Records of in-process controls – periodically

•TABLET -Uniformity mixing,moisture content,weight

variation,Disintegration time,hardness, friability test,leak test of

blisters/strips.

•CAPSULE : Weight Variation, locking length,Disintegration time

etc
SCHEDULE - U
•Details of Date ,time and responsible person for each in-
processing stages.
•Reference of of analytical number report number stating the
result of test and analysis.
• Separate records of the rejection particular and destruction.
•Stage wise theoretical yield and actual productions yield
•Specimen of label /strip, carton with batch coding details like
batch number ,date of manufacturing,date of expiry,retail prices
as applicable ,licenses number etc.
•Signature with date of competent technical staff (FDA-Approved)
responsible for the manufacture
•Review and release by Head - Quality for distribution and sale.
SCHEDULE - U
•Analytical report number
•Name of sample
•Date of receipt of sample]batch/lot number
•Protocol of test applied.(STP)
•Records regarding various tests applied (including
reading and calculation) should be maintained and
necessary reference of these records should be entered.
•Signature of analyst and signature of the person who
checks the report.
• Signature of the Head -QC.
 Particulars to be shown in the Bach Record
as per TGA/MHRA
• MFR and process instruction record/MFR containing
process instruction for each Product and batch size
•BMR is transcription from master MFR by
photocopying,computer print and each documents should
be initialed by competent person before issuing to signify
that it is complete , legible and appropriate.
•% of overage, if any.
•Calculation provision, in case potency is variable
•Location and equipment reference number.
•Method and reference method used for the prepaying,
cleaning and assembling of equipment.
Particulars to be shown in the Bach Record
as per TGA/MHRA
• Step wise manufacturing instruction.
•Checking and cross checking during manufacturing.
(Doer &Checkers)
•Pretreatment of material, if required.
•Check that equipment to be used has been cleared before
using.
•Manufacturing parameters and control
•Safety precaution during and after manufacturing
operation.
•Direction of in process sampling, method,sampling time ,
and date.
•Requirements of bulk storage container ,labels,storage
 Particulars to be shown in the Bach Record
as per TGA/MHRA
•Start time,completion time and yield at each
manufacturing stage.
•Attachment of in plant cleaning tag.
•Details and authorization of deviation,
•Record of specific stage of processing of a batch product
is carried out at other location or by a contractor.
•Identity and record of recovered and reprocessed
material added.
•In-process tags and prints shall be attached with batch
records.
 Particulars to be shown in the
Batch Record as per CFR
Batch production and control records contain complete
information relating to the production and control of each
batch, these records shall include:
A. An accurate reproduction of the appropriate master
production or control record,checked for accuracy dated
and signed.

B.Documentation that each significant step in the

manufacture ,processing ,packing,or holding of the batch
was accomplished ,including
1.Dates
 Particulars to be shown in the
Batch Record as per CFR
2.Identity of individual major equipment and lines used.
3.Specific identification of each batch of component or in
process material used.
4.Weights and measures of components used in the course
of processing .
5.In- process laboratory control results
6.Inspection of packaging and labeling area and after use.
7. A statement of the actual yield and a statement of the
percentage of theoretical yield at appropriate phases of
processing
Particulars to be shown in the Bach Record
as per CFR
8.Complete labeling control records,including specimens
or copies of all labeling used.
9.Description of drug product container and closures .
10. Any sampling performed.
11.Identification of the persons performed and directly
supervising or checking each significant step in the
operation
12.Any investigation made accordance to 211.192
13.Results of examination made in accordance with
211.134
 FLOW CHART OF BMR MOVEMENT
Preparation ,Review and Authorization of
MFR(FD)/MPR(PDC)
Preparation of Draft MasterBMR/BPR with the help
MFR/MPR
Review by all concerned deartments for correctness &
completeness

Approval and authorization of Master BMR

Issuance of BMR/BPR on receipt of requisition from

production
Photocopying form master BMR/BPR & making control
copy by stamping & QA signature.
 FLOW CHART OF BMR MOVEMENT
Entry of details of issuance in BMR/BPR issuance
Register

Receiving of BMR/BPR by production and signing in

the Register

Filling of BMR/BPR on line during manufacturing and

packaging of product.

Submission of completed BMR and BPR to QA

department on completion of batch.

Submission of Analytical
reports by QC
 FLOW CHART OF BMR MOVEMENT
Compiling of BMR,BPR and Analytical Reports
by QA(Batch Records)

Review of Batch Records and Analytical reports by QA

as per check list

Corrective and preventive action

in case,any discrepancies(s).

Preparation of Product Release Certificate

Release of product for commercial dispatch by QA-Head

 FLOW CHART OF BMR MOVEMENT
Archiving of Batch History Record under lock and key
for period defined in respective SOP.

Destruction of Batch History Record as per procedure

defined in the respective SOP
 PREPARATION & AUTHORIZATION
BMR / BPR
• Responsibility – PRODUCTION/PACKING
• Prepare draft BMR/ BPR with the help of
MFR / MPR received from FD & PDC.
• Circulate draft BMR/ BPR for comments
• Make necessary corrections of draft BMR/BPR &
prepare a master .
• Get approval & authorization signatures
 ISSUANCE

BMR / BPR
Responsibility - QA
Based on production plan/On receipt of requisition
Photocopy of master .
Maintain a issuance register
 FILLING
BMR / BPR
• Stores personnel dispense based on ORML & OPML
• Production personnel makes relevant , correct
entries concurrent with the process during each
stage of manufacturing & packaging .
• QA checks for compliance during entire
manufacturing & packaging operations .
• Production submits completed BMR/ BPR to QA
• QC submits completed relevant analytical reports to
QA
 REVIEW &RELEASE

Batches are released only after auditing of batch record

Batch Records are checked thoroughly for:

Availability of all pages, RM tags & in-process labels.

Line clearance records.

Wash water, purified water reports.

Yield at each stage

In-process checks and reports etc.

 REVIEW & RELEASE

Completeness and correctness of each manufacturing

and packaging stages.

Transfer details

Final batch yield and yield reconciliation.

Analytical document and Certificate of Analysis

All entries complete with signatures as appropriate.

 REVIEW &RELEASE

Batch Records are checked thoroughly for:

• If any deviation found in the batch, thorough

investigation should be carried out and only after
proper justification the batch shall be released for
dispatch, till then the batch will be kept under HOLD.

Batch will be released by Authorized person

(Head - QA)
 RETENTION

Completed Batch Records shall be kept in specific

folders and all the records shall be kept in
shelves under lock and key.

These records are preserved for a period as specified

in respective SOP.

Destruction of these batch documents will be done

after completion of storage period as per SOP.
 COMMON ENCOUNTERED DISCREPANCIES

•Overwriting
•Missing of data
•Signature without date
•Use of ditto mark
•Missing of signature.
•Illegible entry
•Overlapping time
• Wrong date and time
•Different time & day,month and year
pattern
 COMMON ENCOUNTERED DISCREPANCIES

•Pencil entry
•Done by and checked by single person.
•Wrong and mismatching reconciliation
•Missing of name of operator or doer.
•Blank spaces
•NA without sign
•Missing of attachments
•Wrong A.R.No entry
•Missing of signature on the specimens.
 COMMON ENCOUNTERED DISCREPANCIES

•Poor/in proper handling of BMR and

attachments.
•Entry in wrong column.
•Usage of eraser/cello tape for correcting
wrong entry.
•Manipulation of entries.
•Non-sequential arrangement of attachments
•NA not written for blank space.
•No justification of Out of specification(OOS)