1.Objective
To lay down procedure for preparation,
review, approval, issuance & retrieval of Standard Operating Procedure.
(SOP)
2.Scope
This procedure is applicable to
preparation of SOP for all the cGMP activities.
3.Responsibilities
User Dept.
QA Dept.
4.Procedure:
The procedure is described further into
sub parts. i.e....
1. Objective
To lay down a procedure for product recall.
2. Scope
This procedure applies to the recall of a batch or batches of any product for which the company is licenced holder, authorised distributor or importer
3....
1. Objective:
To lay down a procedure for performance qualification of LAF, RLAF and dynamic pass box.
Scope:
This procedure is applicable for performance qualification of LAF, RLAF and dynamic pass box Installed...
1. Objective:
To lay down a procedure for cleaning and sterilization of bulk storage tank during batch to batch and product to product cleaning.
Scope:
This procedure is applicable for cleaning and sterilization of bulk...
Author of the document
Prepared by
Designation:
Signature
Date:
Reviewer of the document for correctness
Reviewed by:
Designation:
Signature:
Date:
Approver of the document for use
Approved by:
Designation:
Signature:
Date:
Table of contents:
1. Validation policy
2. Scope
3. Responsibility
3.1 Production department
3.2 Quality control department
3.3 Engineering department
3.4 Quality assurance department
4. Site...
1. Objective
To lay down a procedure for microbiological analysis of water.
2. Scope
This procedure is applicable for analysis of potable, purified and distilled water.
3. Responsibility
Microbiology department
4. Procedure
4.1 Limits: Total viable count:
Grade of Water
Alert Limit
Action Limit
Target...
1. Objective:
To lay down a procedure for preventive maintenance of production equipment, laboratory instruments and utilities.
2. Scope:
This procedure is applicable for preventive maintenance of production equipment,
laboratory instruments and utilities.
3. Responsibility
Engineering department
4. Procedure:
4.1 Frequency and...