Pharmaceutical UNIT 11: Regulatory Aspects of Drug and Cosmetic Quality

Analysis II Control
AY 2023-2024 Dr. Katrina Joy B. Bormate, R.Ph,PhD
1st Semester 10/05/2023

OUTLINE CONTAMINATION
1. R.A 3720  DISADVANTAGES of recalls:
1. It causes a lot of money lost.
2. CGMP
2. Bad publicity damages the good reputation of the
3. CONTAMINATION company.
4. LEGAL REQUIREMENTS 3. Harmful publicity can hurt sales.
5. COMPLAINT RECORDS 4. Recalls have an adverse effect on the employees.
6. PRESERVATION: SAMPLES AND RECORDS  THE FOLLOWING TERMS ARE DEFINED:
• Safe- unable to cause damage, free from danger.
R.A 3720 • Pure- free from contamination
The Food, Drug and Cosmetic Act ( Republic Act No. 3720) • Effective- producing the desired effect.
 This act declared that it is the policy of the state to
ensure safe and good quality supply of food, drug and
cosmetics, and to regulate the production, sale and traffic
of the same to protect the health of the people.
 Several terms are defined under this act. They are:
 Drugs:
1. Articles recognized in the United States Pharmacopeia,
official Homeopathic Pharmacopeia of the United States,
of official National Formulary, or any supplement to any
of them.
2. Articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or
animals.
3. Articles (other than food) intended to affect the structure
or any function of the body of man or animals.
4. Articles intended for use of component of any articles
specified in clause (1), (2) and (3) but does not include
devices or their components, parts or accessories.
 Devices:
1. For use in the diagnosis, cure, mitigation, treatment or
prevention of disease in man or animals or;
2. To affect the structure or any function of the body of man
or animals.
 Cosmetics:
1. Articles intended to be rubbed, poured, sprinkled or
sprayed on, introduced into or otherwise applied to the
human body or any part thereof for cleansing,
beautifying, promoting attractiveness or altering the
appearance.
2. Articles intended for use as a component of any such
article.  Personnel
Authorized:
 The qualified personnel are those with the proper
1. To enter a reasonable hours, any factory, warehouse or
education, training and experience to execute
establishment in which drugs or cosmetics are
technological assignments.
manufactured, processed, packed, or held before and
 They should have an awareness of the importance of
after introduction into the market.
good personal hygiene, wear clean outer garments, and
To inspect in a reasonable manner, such as factory, warehouse,
maintain a high degree of personal cleanliness to
establishment or vehicle and all pertinent equipment, finished or
hygienic practices.
unfinished materials, containers and labeling therein
 Buildings
Buildings should provide for:
CURRENT GOOD MANUFACTURING PRACTICE 1. Adequate space for proper operation of manufacturing,
 This administrative order was patterned after the guidelines processing, packaging, control and storage of products
developed in 1963 by the US FDA with the participation of the and their components,
drug companies. 2. Adequate lighting, ventilization and when necessary for
 The quality control function is to audit or inspect periodically the intended production and control purposes.
the procedures, equipment and facilities employed by the 3. Adequate locker facilities and hot and cold washing
various discipline within the firm engaged in research, facilities.
development, production, control, purchasing, distribution and 4. Adequate supply of potable water under continuous
sale of the product to detect non-compliance to CGMP and to positive pressure in a plumbing system free of defects
correct the said deviations. that could cause or contribute to contamination.

PH ANAL II TRANSCRIBED BY: MARK HAROLD C. GONZALES 1 of 2

 Pharmaceutical UNIT 11: Regulatory Aspects of Drug and Cosmetic Quality
Analysis II Control
AY 2023-2024 Dr. Katrina Joy B. Bormate, R.Ph,PhD
1st Semester 10/05/2023

5. Suitable housing and space for the care of all laboratory

animals.
6. Safe and sanitary disposal
Equipment
Should have the following properties:
 Its surface should not be reactive, additive or absorptive
so as to alter the properties of the drug or cosmetics.
 It should prevent any substance required for its operation
 It should facilitate adjustment, disassembly, cleaning and
maintenance
 It should be of suitable type, size and accuracy for any
intended testing, measuring, mixing, weighing or other
processing or storage operations.
Equipment logbook must cover:
 Date when equipment was used
 Name of the product where equipment was used
 Date when it was cleaned
 Person responsible for cleaning
 Date when equipment was validated
 Result of validation
The scope of this regulation is as follows:
 Definitions
 Current good manufacturing practice
 Buildings
 Equipment
 Personnel
 Components (raw materials)
 Master formula and batch production records
COMPLAINT RECORDS
 Production and control procedures
 Product containers
 Must contain the following:
 Packaging and labeling 1. Name and address of the person complaining
 Laboratory controls 2. Product name, strength and control number
 Finished goods warehouse control distribution records 3. Nature of the complaint
 Stability 4. Reply to the person complaining
 Complaint files 5. Results of the investigation and follow-up action that was
Legal Requirements required
6. If no investigation took place, the record must indiate:
a. Why it was considered unnecessary
b. The name of the person responsible for that decision

PRESERVATION: SAMPLES AND RECORDS

 Components
1. At least two years after the distribution of the last lot of
product incorporating the component has been
completed, or
2. One year after the expiration date of this last lot
incorporating the components.
 Finished Products
1. At least two years after lot distribution is completed, or
2. One year after the expiration date of the product
 Records
1. Drugs: as above
2. Cosmetics: at least 3 years after manufacture is
completed.

REFERENCES
 Dr. Bormate’s PPT
 PH ANAL BOOK

PH ANAL II TRANSCRIBED BY: MARK HAROLD C. GONZALES 2 of 2