SOP for Acceptable Quality Level sampling for Tablets and capsule

May 11, 2020January 27, 2023 Pharmaceutical Guidanace

1.0 OBJECTIVE:To lay down a Standard Operating Procedure for Acceptable Quality Level sampling for Tablets and capsule
2.0 SCOPE:This procedure shall apply to formulation plant of Pharmaceutical Company that manufacture, package, test, and store or distribute drug products.
3.0 RESPONSIBILITY:
- All concerned personnel shall responsible to follow the procedure mention in this SOP.
- Concerned Department Heads shall be responsible for compliance of the procedure.
4.0 ACCOUNTABILITY:

Production and QA Head shall be accountable that this SOP is implemented as per laid down procedure.

5.0 ATTACHMENTS:

– Attachment – I

– Attachment – II

– Attachment – III

6.0 PROCEDURE:

7.0 REFERENCES:

ISO 2859-1:1999

8.0 ABBREVIATIONS:

SOP: Standard Operation Procedure

9.0 DISTRIBBUTION LIST:

Quality Assurance

Human Resource and administration

Production

Quality Control

Warehouse

Engineering

Purchase

10.0 HISTORY OF REVISION:

Version No. Effective Date Reason for revision

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