sop for specification and standard testing raw material packing material and finished product

1.0 OBJECTIVE
1.1 To describe a procedure for the Preparation of Specification & Standard Testing Procedures (STP) for Raw Materials (RM), Finish Products (FP) and Packaging materials(PM).
2.0 SCOPE
2.1 This procedure is applicable to the Quality control department
3.0 RESPONSIBILITY
3.1 Officer/Executive – QC
4.0 ACCOUNTABILITY

4.1 Head –QC
5.0 PROCEDURE

5.1 The Specifications & STP shall be prepared on the approved format on A-4 size paper. Refer Format for Raw Material,

Format for Packaging material , Format for In-process test and for Finished Product.
5.2 Type of font for the contents in STP shall be ‘Times New Roman’ and font size shall be ‘11.’
5.3 All the STP shall be written in clear, unambiguous language, easy to understand and easy to follow.
5.4 Describe the procedure step wise for each test, as sequentially mention in the respective specifications.
5.5 Before writing the procedure for specification parameters, write name of the product (for FP& IP) material name (for RM & PM).
5.6 Each STP shall have a unique number. Once number is allocated to any STP, the same number shall not be repeated to other Test Procedures.
5.7 The numbering system for the Raw Materials, Finished Product and Packaging Material shall be as under: DB/QC/XX/YYZ/AAA and denote C for cephalosporin product.
Type NUMBERING SYSTEM
QC XX YY Z AAA
Raw Material Quality control RM ST S OR P 001
Finished Product Quality control FP ST S OR P 001
Packaging Material Quality control PM ST S OR P 001

ST denoting : Standard Testing, S: Specifications, P: denoting Procedure & AAA : serial no. starting from 001,002,003…….etc.
5.8 After preparation and checking of STS and STP submitted to QA department. And photocopy control and issuance.

5.9 All the STP shall be reviewed within three years (one month prior of expiry date) from the effective date and whenever there is any

change in specifications or in testing procedure amended by the pharmacopoeia or relevant source.
5.10 Any change in STP shall be done through change control procedure.
5.11 All STS, STP, SOP’s and COA shall be printed with “DB” logo at Left hand corner.
5.11 Definitions:
5.11.1 Specifications: A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance

criteria which are numerical limits, ranges, or other criteria for the test described. It establishes the set of criteria to which a drug

substance or drug product should confirm to be considered acceptable for its intended use.

5.11.2 Test Procedure: A sequence of activities which when executed successfully provides documentary evidence that part of the system works as specified.

5.11.3 Raw Material: A general term used to denote starting material, reagents, intermediates, process aids, solvents, excipients,

and API (Active Pharmaceutical Ingredient) intended for use in the production of drug product or drug substances.

5.11.4 Finished Product (Drug Product): A medicinal product that has undergone all stages of production, including packaging in its final container intended for marketing.

5.11.5 Packaging Material: Any material intended to protect an intermediate or API (Active Pharmaceutical Ingredient) or dosage form during storage and transport.

5.11.6 Change Control: A formal system by which qualified representatives of appropriate disciplines review proposed or actual

changes that might affect a validated process status. The intent is determined the needed for action that would ensure that system is maintained is a validated state.

sop for specification and standard testing raw material packing material and finished product

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