Quality Control
Pharma Industry Guidelines
TOTAL QUALITY MANAGEMENT
What Is TQM?
A core definition of total quality
management (TQM) describes a management approach to long–term
success through customer satisfaction. In a TQM effort, all
members of an organization participate in improving processes, products,
services, and the culture in which they work.
TQM focuses...
Pharma Industry Guidelines
Quality Inspections
What are quality inspections?
Defining “quality” for an inspection system is not easy, because an inspection system is only one piece of a larger and complex legal system. At bottom, inspections are meant to...
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“5 Whys” Technique – An Investigation Tool
The Five Whys Technique is a simple problem-solving technique that helps to get to the root of a problem quickly only by asking "Why?" five times successively.
Introduction
The 5-Whys is a simple
brainstorming tool...
Pharma Industry Guidelines
Lean & Six Sigma Methodology – Basics
Lean Methodology
The companies’ need for constant improvement and evolution leads to the search of management tools and methods to foster the development of customer service and to reduce the costs for all associated...
Pharma Industry Guidelines
SOP : Responsibilities of Quality Control Dept.
1.Objective :
To define the
responsibilities of Quality Control Department.
2. Scope :
This procedure is
applicable to all the personnel working in Quality Control Dept.
3. Responsibilities :
QC Analyst, QC in
Charge, Lab Technicians, QC Reviewer, QC Section Head,...
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
STABILITY STUDY PROTOCOL TEMPLATE – Pharmaceutical Industry
STABILITY STUDY PROTOCOL TEMPLATE (FOR ASPIRIN TABLETS 75mg)
Prepared By
Checked By
Approved By
Designation:
Designation:
Designation:
Date:
Date:
Date:
Sr. No.
Content
Page No.
1
Objective of study
2
Responsibilities
3
Product details
4
Packaging and batch details
5
Test parameters and specification
6
Testing schedule
7
Storage condition and stability duration
8
Sample quantity
9
Significant change criteria
10
Test procedure and criteria
11
Report generation
...
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...