part 1: INTRODUCTION

Manufacturing

• The complete set of activities to produce a drug that comprise production and quality control from dispensing of materials to the release for distribution of the finished product

• Large scale basis, for general population

Current Good Manufacturing Practice Guidelines For Drugs

AO 43 s. 1999

September 29, 1999

Date when the AO 43 s. 1999 was issued

AO 43 s. 1999

• Prescribe standard guidelines in the manufacture of drug products

• Ensure that no person or establishment shall manufacture drugs under substandard conditions

• Superceded by AO 2012-0008

Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/s) Guides for the GMP for Medicinal Products

AO 2012-0008

1. Section 1. PERSONNEL

2. Section 2. PREMISES

3. Section 3. EQUIPMENTS

4. Section 4. SANITATION AND HYGIENE

5. Section 5. STORAGE OF MATERIALS

6. Section 6. PRODUCTION

7. Section 7. LABELING

8. Section 8. FINISHED PRODUCT QUARANTINE AND DELIVERY TO WAREHOUSE

9. Section 9. QUALITY CONTROL

10. Section 10. DOCUMENTATION

11. Section 11. SELF INSPECTION

Sections of AO 43 s. 1999

Manager

Under Section 1. PERSONNEL of AO 43 s. 1999, there should be a different _________ in production and quality control

PRC registered, qualified Pharmacist, or any other related profession

Under Section 1. PERSONNEL of AO 43 s. 1999, what are the qualifications needed for production and quality control?

size, design, construction, location

Under Section 2. PREMISES of AO 43 s. 1999, the premises for manufacturing shall be of suitable ____________, ___________, _____________ and ____________ to facilitate proper operation, cleaning and maintenance

contamination

Under Section 2. PREMISES of AO 43 s. 1999, the premises of manufacturing should be protected against _________________

cross contamination

Under Section 2. PREMISES of AO 43 s. 1999, premises for manufacturing should provide for logical movements of materials and personnel with minimal traffic for operations to avoid _______________________

cleaning mobile equipments & storage of cleaning materials

Under Section 2. PREMISES of AO 43 s. 1999, premises for manufacturing should have separate space for ___________ & ____________

Locker / gowning

Under Section 2. PREMISES of AO 43 s. 1999, __________/___________ room shall be directly connected to but separated from processing areas

Experimental animals

Under Section 2. PREMISES of AO 43 s. 1999, ___________________ shall be housed in a separate building

1. Non-reactive, non-absorptive, non-additive

2. Easily and conveniently cleanable

3. Equipments designated for flammable substances should be explosion proof

4. Equipments must be checked for accuracy and well-calibrated

Under Section 3. EQUIPMENTS of AO 43 s. 1999, equipments must follow the following specifications:

1. Installation qualification

2. Operational qualification

3. Performance or Product qualification

Under Section 3. EQUIPMENTS of AO 43 s. 1999, equipment validation involved three distinct stages:

TRUE

TRUE OR FALSE:

Under Section 4. SANITATION AND HYGIENE of AO 43 s. 1999, high level of sanitation shall be practiced in every aspect of manufacturing drug products

1. Personnel

2. Premises

3. Equipment

4. Apparatus

5. Production materials

6. Containers

Under Section 4. SANITATION AND HYGIENE of AO 43 s. 1999, the scope of the sanitation and hygiene program covers:

First Expiry First Out (FEFO)

Under Section 5. STORAGE OF MATERIALS of AO 43 s. 1999, what system is used in storing production materials?

YES, as long as products are stored in secured containers and whose condition will not be affected by exposure to temperature and other conditions

Under Section 5. STORAGE OF MATERIALS of AO 43 s. 1999, is other outdoor storage permissible for materials?

1. Technically stable

2. Well sited

3. Easy to clean and maintain

Under Section 6. PRODUCTION of AO 43 s. 1999, equipment should be the following:

factory sanitation and personal hygiene

Under Section 6. PRODUCTION of AO 43 s. 1999, it must follow high standard of ________________ and ____________________

foreign materials

Under Section 6. PRODUCTION of AO 43 s. 1999, it must be ensured that production will have no contamination from ________________________

cross contamination

Under Section 6. PRODUCTION of AO 43 s. 1999, manufacturing facilities and methods shall be designed to prevent ________________

clutter and untidy

Under Section 6. PRODUCTION of AO 43 s. 1999, there shall be sufficient space provided to minimize ____________________ and ___________________work practices to assure orderly material receivals, warehousing and processing activities

Section 7. LABELLING

The function of the packaging operation is to subdivide and control bulk product

These operations shall be performed under strict control designed to protect the identity, integrity and quality of the final package

Finished product quarantine

It is the last point of control before the product enters the warehouse and becomes available for distribution to the market

Quality Control

It is an essential part of Good Manufacturing Practices to provide assurance that the products will be consistently of a quality appropriate to their intended use

Documentation

In any manufacturing, it is a part of management information system, which includes specifications, procedures, and methods, reports, and records, and other documents that are required for planning, organizing, controlling, and evaluating the whole activities of drug manufacturing

1. Specification for raw materials, intermediate products, bulk products, and finished products

2. QC documents

3. Warehouse and Distribution documents

4. Maintenance, cleaning, and monitoring of equipments

Documentation contains the following information:

Self-inspection

The purpose of _______________ is to evaluate the manufacturer’s compliance with Good Manufacturing Practices on all aspects of production and quality control

1. 3 members

2. experts

3. familiar with GMP

Under Section 11. SELF-INSPECTION of AO 43 s. 1999, qualifications for team of self-inspection are the following:

once a year

Under Section 11. SELF-INSPECTION of AO 43 s. 1999, complete self-inspection must be done at least ______ a year

1. Self-inspection report

2. Evaluation and Conclusion

3. Recommendation and Corrective actions

Under Section 11. SELF-INSPECTION of AO 43 s. 1999, self-inspection report contains the following:

Drug Establishment

is any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines

Drug Outlets

means drugstores, pharmacies, and any other business establishments which sell drugs or medicines

1. Drug Manufacturer

2. Drug Trader

3. Drug Distributor/ Importer/ Exporter

4. Drug Distributor/Wholesaler

Types of Drug Establishments

Drug Manufacturer

Involved in the DIRECT production of a drug

Drug Trader

A registered owner of a drug product that SUBCONTRACTS a licensed drug manufacturer for the manufacture of its products

Drug Distributor/ Importer/ Exporter

IMPORT / EXPORT raw materials, active ingredients and or finished products for its own use or for wholesale distribution

Drug Distributor/Wholesaler

IMPORT raw materials or finished products from local manufacturers for local distribution on a wholesale basis

1. Primary Production

2. Secondary Production

3. Tertiary Production

3 Levels of Production

Primary Production

Processing of raw materials to create active ingredients and ancillary substances used in pharmaceutical productions

Secondary Production

Large- scale processing of finished dosage forms including tablets, capsules or injections

Tertiary Production

Includes packaging and labeling finished products from primary and secondary sources into containers for individual use

1. Production

2. Warehouse Division

3. Research Division

4. Marketing Department

5. Medical Division

6. Regulatory Affairs

7. Quality Assurance

8. Quality Control

9. Engineering and Maintenance

Departments of Manufacturing Pharmacy

Production

• Deals with all stages of manufacturing batches

• Receives Manufacturing Order

Manufacturing Order

Instruction to production department to manufacture a product

Warehouse Division

• Controls the stock of raw materials, intermediate and finished products in charge of checking stocks periodically

• Holds incoming components in quarantine area

Green

What is the color of sticker used if the raw material is approved?

Yellow or Orange

What is the color of sticker used if the raw material is still in quarantine for analysis?

Research Division

Development of new products and improvement of existing products

Marketing Department

Medical Division

• Conducts PE of employees

• Involved in clinical studies

• Prepares drug literatures

• Publishes house or company organs (parang company magazine raw sabi ni ser xD)

Regulatory Affairs

Ensures compliance of company and products with pertinent rules and laws

Quality Assurance

Responsible for approving the specifications of safety and efficacy

Quality Control Department

• Testing each material against the set specification before it can be released for use

• Heart of the Manufacturing Pharmacy

• Analytical functions

• Involves SAR/s

  • Sampling

  • Analyzing

  • Recording systemically

Engineering and Maintenance

Installation, maintenance, and repair of equipment