- 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
