- Objective: To lay down a procedure to define the procedure for the stability of pharmaceutical products .
- Scope: This Standard Operating Procedure is applicable for stability of Pharmaceuticals Product.
- 2.0 SCOPE:This procedure shall apply to formulation plant of Pharmaceutical Company3.0 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:
QC 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
