The complete set of acgtivities to produce a drug that comprise production and quality control from dispensin of materials to the release for distribution of the finished product.
Manufacturing
Prescribed standard guideline in the manufacture of drug products, ensures that no person/establishment shall manufacture drugs under substandard conditions
AO 43 s. 1999
Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/s)
A0 2012-0008
Section 1. Personnel
Organization Structure
Qualification: Production, QC
Section 2. Premises
- Suitable size, design, construction, and location to facilitate proper operation, cleaning and maintenance.
- Protected against contamination
- Provide logical movements of materils and personnel with minimal traffic for operations to avoid cross contaminants
- Separate space for cleaning mobile equipment and storage cleaning materials
- Locker/Gowning room shall be directly connected to but separate from processing areas
- Experimental animals housed separate building
Section 3. Equipment
- Installation Qualification
- Operational Qualification
- Performance/Product Qualification
Equipment should be
- Non-reactive
- Non-absorptive
- Non-additive
- Easily, conveniently cleanable
- Designated form flammable substances
Section 4. Sanitation and Hygiene
High level of sanitation shall be practiced in every aspect of manufacturing drug products
The scope of the sanitation and hygiene program covers:
* Personnel, Premises, Equipment, Apparatus, Production materials, Containers
Section 5. Storage of Materials
First Expiry, First Out (FEFO)
Is other outdoor storage permissible for materials?
Yes. Secured containers and whose condition will not be affected by exposure to temperature and other conditions
Section 6. Production
Basic Manufacturing Requirements
1. Euquipment should be:
Technically suitable
Well-sitted
Easy to clean and maintain
- High Standard of factory sanitation and personal hygiene
- Ensure that no contamination from foreign materials (rust, lubricants, etc)
- Manufacturing facilities and methods shall be designed to prevent cross contamination
- Sufficient space provided to minimize clutter and untidy work practices to assure orderly material receivals, warehousing, and processing activities
Section 9. Quality Control
Heart of Manufacturing Pharmacy
QC provides assurance that products will be consistently of a quality appropriate to their intended use
Analytical Functions
- Sampling
- Inspecting
- Testing of starting materials, intermediate, finished products
- Stability Test
- Environmental testing
- Validation testing
- Review of batch documentation
- Sample Retention Prgram
- Establishment and maintenance of current spcification
Section 10. Documentation
Part of management information system, including specification, procedures, and methods, reports and record and other documents that are required for organizing, controlling, planning, and evaluating the whole activities of drug manufacturing
Section 11. Self-Inspection
Evaluate manufacturer’s compliance with God Manufacturing Practices on all aspects of production and quality control
- 3 members familiar with GMP
- Complete inspection once a year
- Self inspection report
- Evaluation and conclusion
- Recommendation and Corrective Action
Organization or company involved in the manjfactuing, importation, repacking, and distribution of drugs
Drug Establishment
Drugstores, pharmacies, and business establishemnt which sell drugs
Drug Outlets
Establishment engaged in operations involved in the production of a drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting and labeling with the end in view of storage, distribution or sale of the product
Drug Manufacturer
A registered owner of the drug product, procures the materials and packaging components, and provides the production monographs, quality control standards and procedures, but sub-contracts, the manufacture of such product to a licensed manufacturer.
Drug Trader
Establishment that imports/exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other drug establishments or outlets.
Drug Distributor Importer/Exporter
Import raw materials or finished products from local manufacturers for local distribution on wholesale basis
Drug Distributor/Wholesaler
3 Levels of Production
Primary Production
Secondary Production
Tertiary Productiin
Processing of raw materials to create active ingredients and ancillary substances used in pharmaceutical productions
Primary Production
Large-scale processiong of finished dosage forms including tablets, capsules or injections
Secondary Production
