PHARMACEUTICAL

ANALYSIS 1
INTRODUCTION
A. DEFINITION OF TERMS
• Quality (Q) – the totality of char.
Or features of product that bear on
its capacity to satisfy stated or
implied needs

• Quality Assurance (QA) - the sum

total of the organized arrangements
made with the obj. Of ensuring that
products will be consistently of the
quality required by their intended use.
 A. DEFINITION OF TERMS
• Quality Control (QC) – that part of GMP concerned
w/ sampling, specifications and testing, and with the
organization, documentation and release
procedures which ensures that the relevant and
necessary tests are intact and in fact carried out and
that materials are not released for use nor products
released for sale until their quality has been
adjudged to be satisfactory

• Monograph – a doc w/c specifies all the tests to be

conducted on a particular material or product, the
procedure and/or appropriate references containing
the details of the procedure and the expected
results
 A. DEFINITION OF TERMS
Certificate of Analysis - a doc containing
the result of all tests conducted on a
specific material or product to show
compliance or non compliance w/
established std or specifications
approved by resp. personnel

• Good Manufacturing Practice (GMP) –

part of quality assurance that ensures that
products are consistently produced and
controlled according to quality standards
and marketing authorization
QA and QC
inter-relationship
B. Quality Control

• System appropriate to the manufacture of pharmaceuticals

• Mandatory involvement of personnel in the entire product
processing and distribution
• Independent unit with competent staff, adequate and
suitable equipment and facilities
B. Quality Control
1.Objectives:
• Provide assurance that pdts will be consistently of a quality appropriate
for their intended use
• To assure that all quality control arrangement are in place in fact carried
out

2.QC control Points

• Organizational chart, lines of authority, responsibilities
• Personnel training record
Organization of a Typical Pharmaceutical Manufacturing Company
B. Quality Control
3. QC day-today-activities
(sampling, inspection, analysis and release procedure)

• Handling of returned goods

• Handling of reagents and media
• Handling and control of reference standards
• Equipment calibration and maintenance programs
• Safekeeping of results of analyses
• Validation of analytical procedures
• Stability testing program
• In process control (RM-IP-FP)
• Environmental control – ventilation, lighting, environmental condition
• Production record review
• System in handling complaints
• Handling of returned goods Supplier evaluation/ rating
C. Quality Control
Testing of Pharmaceutical Dosage Forms

• Sum of all processes done to ensure that product

possesses all properties ensuring its efficacy and
safety
– General Test Classifications
– Assumptions
• Sampled using an appropriate sampling plan
• Representative of the lot being tested
GENERAL TEST
CLASSIFICATION
1. Packaging
- Material type
- Special Properties
- Integrity
2. Identity Test
- Physical method
- Chemical method
3. Physical properties
-Gross physical appearance
GENERAL TEST
CLASSIFICATION
4. Limit Test
- Gross impurities
- Chemical impurities
- Biological impurities
5. Potency Test
- determine conformance of dosage form to label claim
1. Instrumental methods
2. Chemical methods
3. Biological method = live animals excised animal organs or
tissue biological products
6. Dosage form specific tests
Quality Assurance of
Pharmaceuticals
Quality fitness for use; conformance to Quality specifications
Quality Assurance sum of total arrangements made with the objective of
ensuring that products are of intended quality
ISO 9000 degree to which a set of inherent characteristics fulfills
requirements
Six Sigma Number of defects per million Six Sigma opportunitie
cGMP current good manufacturing practice; part of QA to
ensure that products are consistently produced and
controlled to appropriate standards
Quality control part of cGMP that is concerned with sampling and testing
of products
Standards
• ISO

• ICH

• PIC/S
International Organization for
Standardization
ISO
• A global network that identifies International
Standards required by business, government
and society
• ISO is a non-governmental organization that forms
a bridge between the public and private sectors.
• ISO enables a consensus to be reached on
solutions that meet both the requirements of
business and the broader needs of society.
ISO
• Management and leadership standards

ISO 26000 Social responsibility

ISO 31000:2009 Risk management
ISO 9001:2008 Quality management
ISO 14001:2004 Environmental management
International Conference on
Harmonization
ICH
• International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals
for Human Use
• ICH is a joint initiative involving both regulators and
researchbased industry representatives of the
European Union, Japan and the USA in scientific and
technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of
medicines
ICH
Objectives:
– to increase international harmonisation of technical
requirements to ensure that safe, effective, and high
quality medicines are developed and registered in
the most efficient and cost-effective manner.
– to promote public health, prevent unnecessary
duplication of clinical trials in humans, and minimize
the use of animal testing without compromising
safety and effectiveness
Pharmaceutical Inspection Co-
operation Scheme
PIC/S
• The Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Co-operation Scheme
(jointly referred to as PIC/S)
– two international instruments between
countries and pharmaceutical inspection
authorities, which provide together an active
and constructive co- operation in the field of
GMP
PIC/S
• Mission can be achieved by:
• developing and promoting harmonized GMP
standards and guidance documents;
• training competent authorities, in particular inspectors;
• assessing (and reassessing) inspectorates; and
• facilitating the co-operation and networking for
competent authorities and international
organizations
Association of Southeast Asian
Nations
 ASEAN
• It is an – Laos,
intergovernment
– Malaysia
al organization
of ten Southeast – Myanmar
Asian countries: – Philippines
– Brunei – Singapore
– Cambodia – Thailand
– Indonesia – Vietnam
Aims and Purposes
• To accelerate the economic growth, social
progress and cultural development in the region
• To promote regional peace and stability
through abiding respect for justice and the rule
of law
• To promote active collaboration and
mutual assistance on matters of common
interest
• To provide assistance to each other in the form
of training and research facilities
Food and Drug Administration
RA 9711
An act strengthening and rationalizing the regulatory
capacity of the bureau of food and drugs BFAD by
establisihing adequate testing laboratories and field offices.
Upgrading its equipment, augmenting its human resource
complement, giving authority to retain its income,
renaming it the food and drug administration (FDA),
amending certain sections of republic act no. 3720, as
amended and appropriating funds thereof
Objectives
• To enhance and strengthen the administrative
and technical capacity of the FDA in the
regulation of establishments and products under
its jurisdiction
• To ensure the FDA’s monitoring and regulatory
coverage over establishments and products under
its jurisdiction
• To provide coherence in the FDA’s regulatory system
for establishments and products
FDA - Structure
Centers shall be established per major product category
(drug, food, cosmetics, device)

Field Regulatory Operations Offices will be created

which will include among others, all the field offices,
field or satellite laboratories and the regulatory
enforcement units.
Centers shall be established per Major Product Category namely:
– Center for Drug Regulation and Research
– Center for Food Regulation and Research
– Center for Cosmetics regulation and research (include
HH/Urban Substances)
– Center for Device Regulation, Radiation and Research

Each Center shall be headed by a DIRECTOR and Asst. Director

The FDA Act : Its Significant Features
Establishment of at least one (1) testing laboratory
each in Luzon, Visayas and Mindanao, in addition to the
main testing laboratories at the central office
Luzon - Subic
Visayas -
Cebu
Mindanao - Tagum, Davao
NADRAC
National Adverse Drug Reaction Advisory Committee of the Bureau of
Food and Drug

Functions:
• ensure safety of drug products and other therapeutic agents
through nationwide post marketing monitoring of ADRs
• provide technical assistance to BFAD in the evaluation of ADR
reports
• dissemination of drug related events whether harmful or beneficial
• provision of a venue for interaction with prescribers of
pharmaceutical products