only for two systems

1. BY,
PRAVADA NAMDEO PATIL
roll no. – 022
Guided by: Dr. Varsha Jadhav Mam
quality assurance technique ,2019-2020

2. SIX SYSTEMS OF INSPECTION MODEL
• A model that can help pharmaceutical manufacturers
comply with cGMP regulation

3. QUALITY MANAGEMENT SYSTEM
• A QMS is a collection of business processes
focused on consistently meeting customer
requirements and enhancing their satisfaction.
• It is expressed as organizational goals and
aspirations, policies, processes, documented
information and resources needed to implement
and maintain it.
• Early QMS emphasized predictable outcomes of
an industrial product production line, using
simple statistics and random sampling.

4. Production System
According to the cGMP :
• Quality and manufacturing process and
procedures (and changes to them) must be
defined, approved and controlled.
• Batch numbering and maintaining proper
traceability is required/process validation is
required.
– Track batch, equipment use records and labeling used,
personnel, raw material controls are traceable
• Verification of all steps including sign-off are
required for critical process steps.
• Verification/ validation of computerized processes.
• All batch records must be reviewed and have QA

5. Objectives of Inspection
1. To detect and remove the faulty raw materials before it undergoes production.
2. To detect the faulty products in production whenever it is detected.
3. To bring facts to the notice of managers before they become serous to enable them
discover weaknesses and over the problem.
4. To prevent the substandard reaching the customer and reducing complaints.
5. To promote reputation for quality and reliability of product.
Purpose of Inspection
1. To distinguish good lots from bad lots.
2. To distinguish good pieces from bad pieces.
3. To determine if the process is changing.
4. To determine if the process is approaching the specification limits.
5. To rate quality of product.
6. To rate accuracy of inspectors.
7. To measure the precision of the measuring instrument.
8. To secure products-design information.
9. To measure process capability.

6. FACILITIES AND EQUIPMENT SYSTEM
According to cGMP :
• Areas are designated as clean and dirty,
– Physical separation, equipment and staff for each
operation
• Specify personnel protection equipment and to
prevent contamination by humans
• Areas must operate to a single standard - GMP
or non-GMP
• Need to have designed into areas
– Building materials, air handling, temperature,
microbiology

7. Facilities and building:
operations performed within separate areas are necessary to prevent contamination
including,
1. storage of in-process materials and other materials(containers ,closure, labelling).
2. Manufacturing and processing operations.
3. Storage of released components and drug products and quarantine storage
4. Control and laboratory operations.
5. aseptic processing-cleanable floors, wall ,ceiling and temperature and humidity
control
6.washing, toilet facilities ,sanitation, maintenance.
Equipment:
equipment used in the manufacture, processing, packaging or holding of the drug
product shall be of appropriate size ,design and suitably located to facilate operation
for its intended use and cleaning and maintenance.
1. IQ
2. OQ
3. PQ
4.Equipment construction, cleaning, maintenance, automatic, mechanical, electronic
equipment, filters.