Quality assurance and quality control laboratories are the final step in the production process, verifying that finished drugs meet specifications approved by regulatory authorities. QA ensures product quality through verification, while QC evaluates products through testing to find defects. Both are important but serve different purposes - QA measures quality of processes, while QC measures quality of products. Effective QA and QC are essential for pharmaceutical companies to minimize risks and costs while ensuring safety.

1. Presented By
SAIKAT GHOSH
M-Pharm (Pharmaceutics)
Jadavpur University, Kolkata, INDIA.

2. Pharmaceutical companies are now a days under severe pressure to
bring more drugs to market, more quickly and less cost. Once a drug
is released, increasing focus is placed on ensuring that production
costs are minimized to ensure maximum return. Although the QA/QC
process can take significant time and effort. It will save time and
money in the long run by reducing invalid results. The quality
assurance and quality control laboratories are the final step in the
production process, which verifies whether the finished drug meets
the specifications approved by the FDA ,when the drug was made
available for sale commercially. Businesses performance maximize
with the resources.
.

3.  Quality assurance laboratories provide the final verification of the
product quality (hence safety and efficacy) for the manufactured and
distributed drugs. As such, they are the highest area of the risk in
turn of regulatory scrutiny and the impact of mistakes would be
catastrophic in the term of a product recall or regulatory action.
 The quality control (QC) laboratory is the nerve centre of the
pharmaceutical company –if analyses are incorrect, product is
erroneously released for sale, and people die!. The most commonly
utilized analytical techniques are HPLC (High Performance Liquid
Chromatography), UV-Vis (Ultra wavelength spectroscopy) and
automated dissolution equipment

4.  Many people and organization are confused about the difference between
quality assurance (QA) and quality control (QC) and testing.
They are closely related but they are different concepts;
 Quality assurance: A set of activities designed to ensure that the
development and /or maintenance process is adequate to ensure a
system will meet its objectives.
 Quality control: A set of activities designed to evaluate a developed
work product.
 Testing: The process of executing a system with the intent of finding the
defects.
 QC measures the quality of a product. Testing means “quality control”
 QA measure the quality of processes used to create a quality product.
 QA is the “QC” of “OC”

5.  Quality assurance is the process where the document for the product
to be tested or verifies with actual requirements of the customers. It
includes inspection, auditing, code review, meeting etc.,
Quality control is the process where the product is actually executed
and the expected behavior is verified by comparing with the actual
behavior of the software under test. All the testing types come under
quality control.
 QA activities are concentrated at the end of the inventory process
and effective QA program will include planning, numerous QC
checks during the inventory development and QA audits at strategic
points in the process.
 QA audits are conducted to determine whether QC procedures are
effective and being followed and whether additional QC is necessary
to the inventory development process.

6. Controversy can arise around who should be responsible for QA and QC
activities- i.e., whether a group external to the project management
structure should have responsibility for either QA or QC. The correct
answer will vary depending on the situation.
 While line management should have the primary responsibility for
implementing the appropriate QA, QC and testing activities on a project,
and external QA function can provide valuable expertise and perspective.
 The amount of external QA / QC should be a function of the project risk
and process maturity of an organization. An organization matured,
management and staff will implement the proper QA and QC approaches
as a matter of habit. When this happens only minimal external guidance
and review are needed.

7.  QA activities ensure that the process is defined and appropriate.
Methodology and standard developments are examples of QA activities.
A QA review would focus on the process elements of a project. E.g. are
requirements being defined at the proper level of details
 QC activities focus on finding defects in specific deliverable. E.g. are the
defined requirements the right requirements.
 QA is process oriented and QC is product oriented. Testing therefore is
product oriented and thus is in the QC domains. Testing for quality is not
assuring quality, its controlling it.
 Quality assurance makes sure the result of what u have done or what u
expected.
 QA is more a preventing things ensuring quality in the company and
therefore the product rather than just testing the product. QA is an
independent, objective review of assessing the effectiveness of the QC
program and the quality, completeness, accuracy, precision and
representativeness of the inventory. QC is a system of routine technical
activities to measure and control the quality.
 QC procedures include technical review accuracy checks, and the use of
approved standardized procedures.

8. TQM compared to ISO 9001
ISO 9000 is quality system management standard. TQM is a
philosophy of perpetual improvement. The ISO quality standard sets
in places a system to develop a policy and verifiable objectives. An
ISO implementation is a basis for a Total Quality Management
implementation. Where there is an ISO system, about 75 percent of
the steps are in place for TQM. The requirements for TQM can be
considered ISO plus. Another aspects relating to the ISO standard is
that the proposed changes for the next revision will contain customer
satisfaction and measurement requirements. In short, implementing
TQM is being productive concerning quality rather than reactive.

9. TQM is the foundation for activities which include;
 Meeting customer requirements
 Reducing the development cycle times
 Just In Time / demand flow manufacturing
 Improvement teams.
 Reducing the product and service costs.
 Improving administrative system training
Ten steps to TQM
 Pursue new strategic thinking.
 Know your customers.
 Set true customer requirements.
 Concentrate on prevention, not correction.
 Reduce chronic wastes.
 Pursue a continuous improvement strategies.
 Use structured methodology for process improvement.
 Reduce variation.
 Use a balanced approach.
 Apply to all functions

10. THE PRINCIPALS OF TQM ARE AS FOLLOWS:
1. Quality can and must be managed.
2. Everyone has a customer and is supplier.
3. Processes, not people are the problem.
4. Every employee are the problem.
5. Problem must be prevented, not just fixed.
6. Quality must be measured.
7. Quality improvements must be continuous.
8. The quality standard is defect free.
9. Goals are based on requirements, not negotiated.
10. Life cycle costs, not front end costs.
11. Management must be involved and lead.
12. Plan and organize for quality improvement

11. PROCESS MUST BE MANAGED AND IMPROVED? THIS
INVOLVES:
 Defining the process
 Measuring process performance (metrics).
 Reviewing process performance.
 Identifying process shortcomings.
 Analyzing process problems.
 Making a process change.
 Measuring the effects of the process change.
 Communicating both ways between supervisor and user.