PREPARATION OF SPECIFICATIONS
OBJECTIVE:
To describe in detail the requirements of the specifications of Finished products / Raw materials / Intermediates / In process / Packaging material / Primary standard.
SCOPE:
This procedure applies to all finished products / Intermediates / Raw materials In process sample and packaging material / Primary standard.
REFERENCE:
In House
RESPONSIBILITY:
QC – officers, executives – To prepare the specifications as per SOP.
QC head – To check the prepared specifications as per SOP and requirements.
QA – To ensure that the SOP is being implemented properly and approve the specifications made by QC.
DISTRUBUTION:
Not applicable
ABBREVATION:
IP – Indian pharmacopeia
BP – British pharmacopeia
USP– United state pharmacopeia
IHS – In house specification
QC – Quality control
QA – Quality assurance
COA – Certificate of analysis
PROCEDURE:
1. Prepare a separate specification for each Finished products / Raw materials / Intermediates / In process / Packaging material / Primary standard as given below.
2. Analyse the Product / Material as per R & D Specification or Pharmacopoeial Specification.
3. After Approval of Product / Material based on results of analysis, prepare Specification as per Pharmacopoeia as well as R & D Specification.
4. Specification & name of product are as follows.
4.1 In header give the name of product
4.2 In header give document no. e.g. DOC/QC/R23A –
4.2.1 DOC stands for document
4.2.2 QC stands for quality control
4.2.3 R stands for raw material
4.2.4 23A stands for – 23 for no. of RM and A stands for specification.
4.3 DOC/QC/P01A
4.3.1 P stands for packing material
4.3.2 01 stands for the no. of material
4.3.3 Rest are same as raw material
4.4 DOC/QC/FP01
4.4.1 FP stands for finished product
4.4.2 01 stands for product code.
4.5 DOC/QC/FP01A
4.5.1 01A – stands for product without packing or semi finished product.
5. When preparing the COA of any raw / packing / in process / finished product of A there should be B in the document no.
6. After all above data add details of issuance of document with revision history.
7. Then start for details of material like
7.1 Name – chemical and common name of material
7.2 Structure of raw material
7.3 Molecular weight
7.4 Molecular formula
7.5 CAS No. in pharmacopeia
7.6 Available pack size
7.7 Manufacturer of the raw material
7.8 Supplier of the material
7.9 Storage condition of the material
7.10 Any safety precautions to be taken while sampling – like – under specific light etc.
7.11 Specifications as per – IP/ BP/ USP / IHS
8. Then make a table of tests and specifications of the respective tests.
9. Then add one by one test and its method of analysis in detail, so that anyone can do the analysis with the help of specifications prepared.
10. If some changes are incorporated in pharmacopoeia, before preparing the specification analyse the Product / Material as per current pharmacopoeia & after confirmation of results and Approval prepare Specification as per current pharmacopoeia.
11. Review the specification after any changes took place in Specification or In-House Specifications.
12. Include the test as per Pharmacopoeia as well as In-House Specification for raw material and finished product.
13. Include the In house tests for packing material.
FREQUENCY:
Whenever required and there is new material or finished product.
ANNEXURE:
Annexure I – Specification
Annexure II – COA
TEST SPECIFICATION
Description It include physical description of tablet like color, shape etc.
Average weight of 20 tablet In grams
Average diameter In mm
Average Thickness In mm
Disintegration time In seconds
Hardness In kg/cm2
pH of solution
Assay As per label claim
Microbial counts:
Total Bacterial count In cfu/gm as per pharmacopeia
Fungal Count In cfu/gm as per pharmacopeia
Pathogens:
E coli Should be absent
Salmonella Should be absent
Pseudomonas Should be absent
s. aureus Should be absent
B) For Raw materials
Sr.No Test Specification Result
C) For Packing materials
Sr.No Test Specification Result
Annexure II – COA
A) For tablets
A.R. No. : Batch Size :
Batch No. : Date of Sampling :
MFG Date : Date of Analysis :
EXP Date : Date of Release :
Qty. Sampled :
Test Specification Result
Remark: Above sample Complies / Does not Comply with prescribed Standard.
____________ _________
Analyzed By Date
_____________ _________
Approved by Date
B) For Raw material and packing material
Product:
GRN No: A.R.No:
Date: Lot No:
Challan No: Quantity Received:
Quantity Sampled: Date of Sampling:
Manufacturer: Date of Analysis:
Supplier: Date of Release:
Test Specification Results
Remarks :- Above sample complies / does not comply as per IP/BP/USP/IHS.
____________ _________
Analyzed By Date _____________ _________
Approved by Date