PHARMACEUTICAL QUALITY SYSTEM

PIC/S Part I Chapter 1

PE 009-14

ANGELI B. CASALA
Food-Drug Regulation Officer III
Regional Field Office-National Capital Region
 PRESENTATION OUTLINE
I. Principle
II. Importance of Senior Management
III. Quality Management
IV. Basic Requirements of GMP
V. Basic Requirement for Quality Control
VI. Product Quality Review
VII. Quality Risk Management (Principle)
 Principle
❖ The holder of the Manufacturing Authorization is responsible
for the quality of the manufactured medicinal products;
ensure that products manufactured are fit for their intended
use, comply with the requirements of the Marketing
Authorisation or Clinical Trial Authorisation, as appropriate,
and do not place patients at risk due to inadequate safety,
quality or efficacy

❖ The attainment of the quality objective is the responsibility of

the senior management and staff.
 Pharmaceutical Quality System
Senior Management is responsible to attain the quality
objective and requires participation and commitment by
the staff in different department and at all levels within the
company, by the company’s suppliers and its distributors.

There should be a comprehensively designed and

correctly implemented PQS incorporating GMP and QRM
to achieve the quality goals.
 Quality Management
Quality Management is a wide-ranging concept, which
covers all matters, which individually or collectively
influence the quality of a product. It is the sum total of the
organised arrangements made with the objective of
ensuring that medicinal products are of the quality
required for their intended use

Quality Policy defines the goals and direction of the

company
PQS Model

Reference : ICH Q10 (ispe.org)

 A Pharmaceutical Quality System appropriate for the
manufacture of medicinal products should ensure that:
1. Product realization is achieved
2. Product and process knowledge is managed throughout
all lifecycle stages.
3. Medicinal products are designed and developed taking
into account the requirements of Good Manufacturing
Practice (GMP).
4. Production and control
operations are clearly specified
and GMP adopted

5. Managerial responsibilities are

clearly specified
6. Supplier Qualification
7. Outsourced Activities
8. Effective monitoring and control system for process
performance and product quality.
9. Results of product and processes monitoring
10. Controls for intermediate products, in-process and
validations are carried out.
11. Continuous improvement
12. Evaluation and implementation of change
13. Application of root cause analysis
14. Medicinal products are not sold or supplied before an
Authorised Person has certified that each production batch
has been produced and controlled in accordance with the
requirements of the Marketing Authorisation and any other
regulations relevant to the production, control and release of
medicinal products
15. Storage, Distribution and Handling of medicinal
products.

16. Self Inspection and/or quality audit process.

 Senior Management
❖ Responsible to ensure an effective Pharmaceutical
Quality System is in place, adequately resourced and
that roles, responsibilities and authorities are defined,
communicated and implemented throughout the
organization.
❖ Involvement in Periodic Management review
❖ Management Responsibilities should be incorporated in
the Quality Manual or equivalent documentation.
 Good Manufacturing Practice for Medicinal Products

Good Manufacturing Practice (GMP) is that part of Quality

Management which ensures that products are consistently
produced and controlled to the quality standards
appropriate to their intended use and as required by the
Marketing Authorisation, Clinical Trial Authorisation or
product specification. Good Manufacturing Practice is
concerned with both production and quality control.
 Basic Requirements of GMP:
1. All manufacturing processes are clearly defined,
systematically reviewed in the light of experience and
shown to be capable of consistently manufacturing
medicinal products of the required quality and complying
with their specifications
2. Critical steps of manufacturing processes and significant
changes to the process are validated
3. All necessary facilities for GMP are provided
4. Instructions and Procedures
5. Procedures are carried out correctly and operators are
trained to do so
6. Records are made, manually and/or by recording
instruments, during manufacture.
7. Significant deviations are fully recorded.
8. Records of Manufacture and Distribution
9. Good Distribution Practice
10. System for Product Recall
11. System for Handling of Complaints
 QUALITY CONTROL
Quality Control is that part of Good Manufacturing Practice
which is concerned with sampling, specifications and
testing, and with the organisation, documentation and
release procedures which ensure that the necessary and
relevant tests are actually carried out and that materials
are not released for use, nor products released for sale or
supply, until their quality has been judged to be
satisfactory.
 Basic Requirement of Quality Control
1. Adequate facilities, trained personnel and approved
procedures
2. Qualified Personnel and Approved Methods
3. Validated Test Methods
4. Records
5. Compliance of Finished Products
6. Results of inspection and that testing of materials,
intermediate, bulk, and finished products is formally
assessed against specification
7. No batch of product is released for sale or supply prior
to certification by an Authorised Person that it is in
accordance with the requirements of the relevant
authorisations.
8. Sufficient reference samples
 Product Quality Review (PQR)

A regular periodic PQR should be conducted with the

objective of verifying the consistency of the existing
process, the appropriateness of current specifications
for both starting materials and finished product, to
highlight any trends and to identify product and
process improvements. Such reviews should normally
be conducted and documented annually.
 PQR should consist review of at least the following:
1. Starting and packaging materials
2. Critical in-process controls and finished product results
3. All batches that failed to meet established
specification(s) and their investigation
4. All changes
5. Marketing Authorizations
6. Results of the stability monitoring programme and any
adverse trends
7. All quality-related returns, complaints and recalls
8. Corrective Actions
9. Qualification status of relevant equipment and utilities
10. Contractual Agreements

❖ Quality reviews may be grouped by product type, e.g.

solid dosage forms, liquid dosage forms, sterile
products, etc. where scientifically justified
❖ Marketing Authorisation holder is not the manufacturer,
there should be a technical agreement in place between
the various parties that defines their respective
responsibilities in producing the product quality review.
The Authorised Person responsible for final batch
certification together with the Marketing Authorisation
holder should ensure that the quality review is
performed in a timely manner and is accurate
 Quality Risk Management
❖ A systematic process for the assessment, control,
communication and review of risks to the quality of the drug
(medicinal) product.

Principle of Quality Risk Management:

• The evaluation of the risk to quality is based on scientific
knowledge, experience with the process and ultimately links
to the protection of the patient;

• The level of effort, formality and documentation of the

Quality Risk Management process is commensurate with the
level of risk.
❖ Identifying Risk
❖ Preparing Risk Control
Measures
❖ Assessment of residual risk
after Risk Control measure
❖ Risk Acceptance
❖ Determination the
acceptability of residual risk
END

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