The pharmaceutical industry is a highly regulated industry by Drug Departments. Every action in the pharmaceutical manufacturing company needs to be documented and verified. Action without documentation is understood as manipulation or out of specification because without SOP no action is permissible in this industry. Therefore, to meet the requirements, proper SOP for maintaining a record of analysis for Raw materials, Finished goods, and packing material is prepared in every company. Â
After the implementation of the SOP for maintaining a Record of the analysis of raw materials, packaging materials, and finished products, every document should have a prescribed proforma and unique identity numbers.
SOP for Maintaining a Record of Analysis for Raw materials, Packaging materials, and finished products:
Objective: To lay down a procedure for Maintaining the record of analysis of raw material, packaging material & finish products.
2. Scope: The procedure of this SOP shall be applicable to Q.C. Department of XYZ Pharma
3. Responsibility : Quality Control Chemist
4. Accountability : Quality Control Manager
5. Abbreviations :
S.O.P. : Standard Operating Procedure
QC : Quality Control
QA : Quality Assurance
 6. Procedure of maintaining a record of raw material:Â
6.1 Raw Materials
6.1.1. The record of receipt of each delivery of each raw material has the following additional details:
Date of receipt of material
Name of material on the invoice/challan/ delivery note and/or containers, if the name is different from the normally accepted name.
The supplier’s or manufacturer’s batch or reference number.
The number of containers received.
The batch identifying number is assigned on, or after, receipt.
The date of sampling.
The record of testing of each raw material is also include the date of receipt of the sample for testing.  Date of testing.The batch identifying number (or the laboratory reference number). The results of all the tests carried out. Identity and signature of the person(s) who performed the tests.
The signature of a second person shows that the records have been reviewed for accuracy, completeness, and compliance (or non-compliance) with prescribed standards.
The signed release or rejection (or any other status decision) by Quality control
Records are, where appropriate, include,
A statement of the weight or measure of the sample used for each test.
A record of all calculations performed in connection with the test, including units of measure, conversion factors, and equivalence factors.
A complete record of data secured in the form of graphs, charts, and spectra from laboratory instrumentation, was properly identified to indicate the material and the lot tested.
A clear statement of the assigned potency where this may vary from batch to batch of material.
Packaging materials record procedure:
The record of receipt of each delivery of each packaging material has the following additional details:
Date of receipt of material.
Supplier’s reference or batch number.
Any batch identifying number assigned on, or after, receipt.
The date of sampling.
The record of testing of each packaging material also includes:
Date of receipt of sample for testing.
Date of testing (or inspection)
The batch identifying number (or the laboratory reference number).
The results of testing and inspection.
Identity and signature of the person(s) who performed the test.
The signature of a second person shows that the records have been reviewed for completeness, and compliance (nor non-compliance) with established standards.
The signed release or rejection (or any other status decision) by Quality control.
Intermediates, Bulk and Finished Products:
Records of analysis should also include:
(a) The date of manufacture.
(b) The date of testing.
(c) The signed release or rejection (or any other status decision) by Quality control.
6.4 Retention of Records
The time period to keep the record of laboratory analysis by the manufacturer is given in the Drugs and Cosmetics Rules 1945.
References:
- Documentation and Records: Harmonized GMP Requirements-NCBI
- Guidance for Preparing Standard Operating Procedures (Sops)-IOSR
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