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Manufacturing > Intro > Flashcards

Intro Flashcards

1
Q

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.

A

Manufacturing

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2
Q

Prescribed standard guideline in the manufacture of drug products, ensures that no person/establishment shall manufacture drugs under substandard conditions

A

AO 43 s. 1999

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3
Q

Adoption and Implementation of the Pharmaceutical Inspection Cooperation Scheme (PIC/s)

A

A0 2012-0008

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4
Q

Section 1. Personnel

A

Organization Structure
Qualification: Production, QC

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5
Q

Section 2. Premises

A
  • 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
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6
Q

Section 3. Equipment

A
  1. Installation Qualification
  2. Operational Qualification
  3. Performance/Product Qualification
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6
Q

Equipment should be

A
  • Non-reactive
  • Non-absorptive
  • Non-additive
  • Easily, conveniently cleanable
  • Designated form flammable substances
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7
Q

Section 4. Sanitation and Hygiene

A

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

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8
Q

Section 5. Storage of Materials

A

First Expiry, First Out (FEFO)

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9
Q

Is other outdoor storage permissible for materials?

A

Yes. Secured containers and whose condition will not be affected by exposure to temperature and other conditions

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10
Q

Section 6. Production

A

Basic Manufacturing Requirements
1. Euquipment should be:
Technically suitable
Well-sitted
Easy to clean and maintain

  1. High Standard of factory sanitation and personal hygiene
  2. Ensure that no contamination from foreign materials (rust, lubricants, etc)
  3. Manufacturing facilities and methods shall be designed to prevent cross contamination
  4. Sufficient space provided to minimize clutter and untidy work practices to assure orderly material receivals, warehousing, and processing activities
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11
Q

Section 9. Quality Control

Heart of Manufacturing Pharmacy

A

QC provides assurance that products will be consistently of a quality appropriate to their intended use

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12
Q

Analytical Functions

A
  • 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
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13
Q

Section 10. Documentation

A

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

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14
Q

Section 11. Self-Inspection

A

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
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15
Q

Organization or company involved in the manjfactuing, importation, repacking, and distribution of drugs

A

Drug Establishment

16
Q

Drugstores, pharmacies, and business establishemnt which sell drugs

A

Drug Outlets

17
Q

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

A

Drug Manufacturer

18
Q

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.

A

Drug Trader

19
Q

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.

A

Drug Distributor Importer/Exporter

20
Q

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

A

Drug Distributor/Wholesaler

21
Q

3 Levels of Production

A

Primary Production
Secondary Production
Tertiary Productiin

22
Q

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

A

Primary Production

23
Q

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

A

Secondary Production

24
Q

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

A

Tertiary Production

25
Q

Departments in Manufacturing Pharmacy

A

Production
Warehouse Division
Research Division
Marketing Department
Medical Division
Regulatory Affairs
Quality Assurance
QC Department
Engineering and Maintenance

26
Q

Deals with all stages of manufacturing batches, receives manufacturing order

A

Production

27
Q

Controls stock of raw materials, intermediate, and finished products in charge of checking stocks periodically, holds incoming components in quarantin area

A

Warehouse Division

28
Q

Development of new products and improvement of existing products

A

Research Division

28
Q

Development of new products and improvement of existing products

A

Reserach Division

29
Q

Advertisement and product promotion

A

Marketing Department

30
Q

Ensures compliance of company and products with rules and laws

A

Regulatory affairs

30
Q

Conducts physical examination of employees, involved in clinical studies, prepared drug literatures, publish company organization

A

Medical Division

31
Q

Approving the specifications of safety and efficacy, prepares SOP

A

Quality Assurance

32
Q

Test materials against set specification before releasing for use

Sampling, Analyzing, Recording

A

Quality Control Department

33
Q

Installation, maintenance, and repair of equipment

A

Engineering and Maintenance

Manufacturing (13 decks)

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