Pharma Industry Guidelines
SOP : Cleaning of Glassware
1.Objective :
To lay down the procedure
for Cleaning
of Glassware used in laboratory.
2. Scope :
This SOP provides general instructions
for Cleaning
of Glassware used in laboratory.
3. Responsibility :
Quality Control
Department
4. Procedure :
4.1 Glassware Cleaning...
Pharma Industry Guidelines
SOP-Responsibility of Quality Unit
1.Objective :
To define the responsibilities of Quality
Unit.
2. Scope:
This procedure is applicable to all
personnel working in Quality Unit.
3.Responsibilities :
Quality
Control, Quality Assurance, Microbiology Department
4. Procedure :
Quality should be the
responsibility of all persons involved in manufacturing. Each...
Pharma Industry Guidelines
Process Performance Qualification Protocol/Process Validation Protocol
PV ProtocolDownload
Process Performance
Qualification Protocol
Name
of Product:
Stage:
Product
Code:
Plant:
Sr. No.
Table of Contents
Page No.
1.
Purpose
...
Pharma Industry Guidelines
SOP of Control Sample Management
1.Objective :
To lay down procedure
for handling of Control Sample. Also known as Retention Sample or Reserved
Sample.
2. Scope :
This procedure is
applicable for sampling, storage, issuance and destruction of Control Sample of
Key Raw material,...
Pharma Industry Guidelines
SOP -List of Stamps
Objective
:
To lay down procedure for
usage of stamps for issuance of documents by QA.
Scope
:
This procedure is
applicable to all documents, which are issued by QA to other departments.
Procedure:
A.Master Copy:
It is the final approved / authorized copy...
Microbiology
Do’s & Dont’s in Microbiology Lab
Objective :
To
lay down the procedure of Do’s and Don’ts to be
followed in Microbiology Laboratory.
Scope:
Applicable to Microbiology Lab.
Responsibility:
All
persons working in Microbiology Lab.
Procedure:
Do’s in Microbiology Lab
Always maintain cleanliness & hygienic conditions in Lab.Personal hygiene...
Pharma Industry Guidelines
SOP on CAPA | Corrective Actions and Preventive Actions in Pharma Industry
Objective :
To lay down the procedure of for identification, evaluation, implementation,effectiveness monitoring, closure and documentation of Corrective Actions and Preventive Actions (CAPA).
2.Scope:
This SOP is applicable for all Corrective
Actions and Preventive Actions (CAPA) initiated for...
Pharma Industry Guidelines
SOP – Good Documentation Practices in Pharma Industry
1.Objective :
To lay down a procedure for good documentation practices.
2. Scope:
This procedure is applicable to all cGxP documents (electronic & manually generated) used in the manufacturing, packaging, labeling, testing, storage and distribution of Drug...