The document discusses quality assurance (QA) and total quality management (TQM) principles for the pharmaceutical industry. It defines QA as organized arrangements to ensure products meet quality standards for intended use. Key QA activities mentioned include facility and equipment validation, batch record preparation, auditing, and compliance. The document also discusses good manufacturing practices (GMP) as an integral part of QA, and lists its 10 principles. Quality control (QC) is defined as procedures to ensure products adhere to predefined quality criteria. TQM is described as integrating all functions to continuously improve quality and achieve customer satisfaction.

1. Dr. B.Poornima,
Associate Professor,
Department of Pharmaceutical Analysis,
Krishna Teja Pharmacy College, Chalawada Nagar,
Tirupati
QC, QA & TQM

3. Quality Assurance
It is the sum total of
the organized
arrangements with the
objective of ensuring
that products will be
of the quality required
for their intended use.

5. QA
Facility Validation
Equipment
Validation
Process
Validation
Cleaning
Validation
Batch Record Preparation
Issue & Review
Line Clearance
Online GMP inspection
IPQA

6. QA
C GMP
Training
Self Auditing
Annual Product Review
Market Compliance
Product Recall
Plant &
Regulatory
Affairs
DMF Submission
ANDA Submission
Annual Updates
Documentation
SOP/ Protocol
preparation &
Review
Vender
Qualification
Document
Review
Process
Control

8. GMP
• Part of QA which ensures that products
are consistently produced & controlled to
the quality standards appropriate to their
use.
• GMP is an integral part of QA.

9. Ten Principles of GMP
1. Design & construct the facilities & equipments
properly.
2. Follow written procedures & Instructions
3. Document work
4. Validate work
5. Monitor facilities , equipment & Perssonel
6. Write step by step operating procedures & work on
instructions
7. Design, develop & demonstrate job competence
8. Protect against contamination
9. Control components & product related processes
10. Conduct planned & periodic audits

10. GMP includes
 Quality Management
 Perssonel
 Buildings & Facilities
 Process equipment
 Documentation & Maintenance of Records
 Materials & Management
 Production & In process control
 Storage & Distribution
 Laboratory control
 Validation
 Rejection & Reuse of materials

11. Quality Management
 Quality management ensures that an
organization, product or service is consistent.
 It has four main components:
o Quality planning
o Quality control
o Quality assurance &
o Quality improvement

12. Perssonel

14. Buildings &
Facilities
Design &
Construction
Lighting Utilities
Sewage & Refuse
Water
Containment
Sanitation
&
Maintenance

15. Design &
Construction
Calibration
Equipment
Maintenance

16.  Documentation system.
Records of Raw materials, Intermediates, API
labeling & Packaging Materials.
Master Production & Control records.
Batch Production & Control records.
Laboratory Control records.
Batch production record review.

17. List of important documents
in GMP
• Policies
• SOP
• Specifications
• MFR (Master Formula Record)
• BMR
• Manuals
• Master plans/ files
• Validation protocols
• Forms & Formats
• Records

18. • All production, Control and distribution
records should be retained for at least 1 year
after expiry date of the batch.
• For APIs with retest dates, records should be
retained for at least 3 years after the batch is
completely distributed.

19. Materials Management
There should be written
procedures describing
receipt, identification,
quarantine, storage,
handling, sampling, testing,
and approval or rejection of
materials.

20. Storage & Distribution (Ware House
activities )
Ware house
Quarantine
sampling
QC
Approved
Storage area
Finished/
Bulk
products
Packing
material
Dispensed
REJECTED

21. Validation
 It is an documenting that a process or system
meets its pre-determined specifications and
quality attributes.
 It includes
Process Validation
Analytical method Validation
Cleaning Validation
Validation for dosage forms
Validation for Bulk &
Sterile products

22. Rejection & Re-use materials
Records should be maintained for these
materials. Documentation should include
Name & Address of the Consignee
Intermediate or API batch number, and
quantity returned.
Reason for return
Use or disposal of the returned Intermediate or
API.

23. Importance of GMP
– A poor quality medicine may contain toxic
substances that have been unintentionally added.
– A medicine that contains little or none of the
claimed ingredient will not have the intended
therapeutic effect.

25. Quality Control
Quality control (QC) is a procedure or set of
procedures intended to ensure that a
manufactured product or performed service
adheres to a defined set of quality criteria or
meets the requirements of the client or
customer.

26. Responsibilities of QC
Validated test methods
Release of a batch of product only
after certification by Qualified
person
Maintenance of sufficient
retention samples of starting
materials and final product for
future examination if necessary.
Recording & investigation of out of specification results,
changes, incidents/ deviations.
Approved procedures, trained
personnel, facilities for sampling,
inspection & testing of raw
materials, bulk & finished products.
Maintenance of records to
demonstrate all procedures have
been carried out.
certification of starting materials
that specifies quality & purity their
storage, Labeling before using.

28. Total Quality Management
TQM is the integration of all functions and
processes within an organization in order to
achieve continuous improvement of the quality
of goods and services. The goal is customer
satisfaction.

31. Principles of TQM
• The basic principles for the Total Quality
Management (TQM) philosophy of doing
business are ……
• To satisfy the customer,
• satisfy the supplier, and
• continuously improve the business processes.

32. • Satisfy the customer
• The first and major TQM principle is to satisfy
the customer--the person who pays for the
product or service.
• Company philosophy
• A company that seeks to satisfy the customer
by providing them value for what they buy and
the quality they expect will get more repeat
business, referral business, and reduced
complaints and service expenses.

33. • Satisfy the supplier
• A second TQM principle is to satisfy the supplier,
which is the person or organization from whom
you are purchasing goods or services.
• A company must look to satisfy their external
suppliers by providing them with clear
instructions and requirements and then paying
them fairly and on time.
• It is only in the company's best interest that its
suppliers provide it with quality goods or
services, if the company hopes to provide quality
goods or services to its external customers.

34. • Continuous improvement
• The third principle of TQM is continuous
improvement by
• Working smarter, not harder
• Worker suggestions
• Quality methods