Scribd
Upload
2 views

Documentation

The document outlines the legal requirements and specifications necessary for maintaining comprehensive documentation in manufacturing, including product specifications, master formulae, and batch manufacturing records. It emphasizes the importance of control over document updates, systematic cancellation of outdated documents, and the need for QA approval for changes. Additionally, it details the necessary contents of master formulae and batch records, as well as the requirements for distribution documents and log books for traceability and compliance.

Uploaded by

Haritha Sameeraja
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
2 views

Documentation

The document outlines the legal requirements and specifications necessary for maintaining comprehensive documentation in manufacturing, including product specifications, master formulae, and batch manufacturing records. It emphasizes the importance of control over document updates, systematic cancellation of outdated documents, and the need for QA approval for changes. Additionally, it details the necessary contents of master formulae and batch records, as well as the requirements for distribution documents and log books for traceability and compliance.

Uploaded by

Haritha Sameeraja
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPT, PDF, TXT or read online on Scribd
You are on page 1/ 14

Documentation

SR Parthasarathy
Legal Requirements
 Are the following documents available & are they
comprehensive in contents?
 Product specifications
 Manufacturing specifications
 Packaging specifications
 Master formulae cards
 Batch manufacturing records
 Batch packing records
 SOP for every important activity
 Control specifications
 Control records
 Distribution records
Legal Requirements
 Is there a control on document to ensure that
only updated documents are on shop-floor?
 Is there a SOP for making SOP & SOP for handling
/ storage / destruction / of outdated document?
 Is revision date & renewal date available on all
documents?
 Are minor changes recorded by “Amendment
Form”?
 Are major changes recorded by “process change
request form”?
 Is any change approved ultimately by QA?
Legal Requirements
 Is it instructed to concerned persons that even
the cancellation should be done systematically &
the old matter should be readable?
 In case of corrections, are the signed &
explanations written for corrections?
 Is QC having a check-list for checking BMR before
release of goods?
 Where are records stored & for how much time
are they stored after their shelf-life?
 If all records are stored electronically, is the
software & hardware validated & instituted by
authorized personnel only?
Specifications
 Are specifications available for every starting Raw
& Packing materials which include organoleptic
characteristics also?
 Are specifications available for auxiliary materials
like disinfecting agents, fumigating materials,
pesticides, lubricants which may have an indirect
effect on product quality?
 Is it assured that no changes in specifications are
done without approval by QA / R&D / Production
even for economy of purchase?
 Is there periodic review of specifications?
Master Formulae
 Is master formulae available for each product &
batch size?
 Ideal contents of M.F.C
 Name & Strength of product, generic and brand
name
 Brief chemistry & category of active ingredient
 Production No., Batch size & effective date &
review date
 Name, Pharmacopoeial status wt. of each
ingredient
 Total weight of dosage form
 Physical specifications of materials – sieve size –
Bitterless etc.
Master Formulae
 Content of every ingredient per dosage form
 List of equipment required with their capacity
 Theoretical weight / volume of appropriate steps
 % yields limits of appropriate steps
 Product related instructions e.g. light,
temperature humidity
 Procedure on manufacturing, packing
 Time required for every important step
 Maximum time allowed between two consecutive
steps
Master Formulae
 Product related & safety precautions
 Steps where signature of “responsible person” is
a must
 I.P.Q.C to be followed
 Specifications, parameters of important steps like
coated, uncoated etc.
 List of packaging materials with specifications
 Specimen copy of label foil, carton with sign &
date
 Detail packaging procedure / labelling procedure
 Compendial & in-house specifications
 Speeds of machines / equipments to be used
Master Formulae
 Sampling & testing procedure
 Storage condition of product
 Shelf life of product
 Limit for adding recovery
 Reprocessing procedure
 Line clearance to be followed
 Sign of prepared / checked / authorized by
 Any amendment done / product histroy file.
 Name of Mfr. of active ingredient
 The MFC & Batch manufacturing record should be exactly
matching for procedure & qualities.
 Are MFC & SOP explained to the workers in the local
language? Are they available in the local language?
Batch Manufacturing
Records
 Traceability is very important
 Date and time of every step
 Dispensing records
 Preserving the dispensing lables
 Persons doing & supervising the steps
 Line clearance records
Batch Manufacturing
Records
 Mfg. / Expiry date
 I.P.Q.C checks – preferably easily
identifiable
 The BMR should travel with the batch
process
 Review of BMR by QA before release
 Investigation of discrepancies in BMR by
QA / Production
 Procedure for investigating two batches
before & after the concerned batch
Distribution Documents
 Are the documents of distribution accurate
enough to allow a speedy recall of product
from market in case of product recall
need?
 Are details of telephone / fax / e-mail and
other means of distribution correctly
stored?
Records / Log Books
 Are individual log books for maintenance,
cleaning & operation use of major
machines available?
 Do log books show the date, time product
& lot no manufactured?
 Are log books signed by production &
engineering personnel?
 Do batch no’s always follow a
chronological / sequence in log books?
 If no, is a reason given for the same?
 Thank you

You might also like