Pharma Industry Guidelines
SOP of Signature Log | Pharmaceutical Industry
1. Purpose : To lay down the procedure for signature log.
2.Scope : This procedure is applicable to all employees working in a company...
Pharma Industry Guidelines
SOP ON SOP (HOW TO PREPARE SOP) – PHARMACEUTICAL INDUSTRY
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....
Pharma Industry Guidelines
SOP for Product Recall in Pharmaceutical Industry
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....
Pharma Industry Guidelines
SOP for Performance Qualification of LAF, RLAF and Dynamic Pass Box
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...
Pharma Industry Guidelines
SOP for Cleaning and Sterilization of Bulk Storage Tank
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...
GMP & Guidelines
Validation Master Plan for Pharmaceutical Industry
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...
Microbiology
SOP for Microbiological Analysis of Water
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...
Pharma Industry Guidelines
SOP for Preventive Maintenance of Production Equipment, Laboratory Instruments and Utilities in Pharmaceuticals
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...