Good Manufacturing Practice

Question 1

Good Manufacturing Practice - GMP

Answer 1

Quality concept and consists of a set of policies and procedures for manufacturers of drug products

Question 2

What does the FDA say about GMPs?

Answer 2

• They provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities
• adherence to GMP regulation assure identity, strength, quality, and purity of drug products by requiring that manufacturers of meds adequately control manufacturing operations

Question 3

ICH

Answer 3

International Conference on Harmonization
- form in 1990 in Brussels
- members = regulatory agencies and Industry representatives
- majority of reps = US, Europe, Japan

Question 4

ICH’s mission

Answer 4

• to make recommendations towards achieving greater harmonisation in interpretation and application of technical guidelines and requirements for pharmaceutical product registration -> reducing or obviated duplication of testing carried out during research/development of new human medicines

Question 5

cGMP

Answer 5

current GMP
- focuses on potential risks assoc with manufacturing of high risk dosage forms (sterile forms) and manufacturers w/ prev offenses, and implements a consistent approach that involves innovative science based policies
- adherence assures ID, strength, quality, and purity of drug products by requiring that manufacturers control manufacturing operations

Question 6

Key Elements of GMP

Answer 6

1. People Involved
2. Environment and equipment
3. Procedures (Operations)
4. Quality Systems (Management)

Question 7

People - Training

Answer 7

• all personnel have appropriate edu (ongoing GMPs or other cont. training) and/or have the practical experience
• maintain records of edu and training and update when needed

Question 8

People - Hygiene

Answer 8

• all personnel that have direct contact w/ …
  1. raw and/or packaging material
  2. in-process materials and any unpackaged products
  3. processing equipment
  … follow practices to protect products against contamination
• health and hygiene program must be in writing

Question 9

Environment

Answer 9

1. adequate size of buildings designed to facilitate maintenance
2. cleaning and sanitary operations
3. prevent entry of insects and other animals
4. facilitate waste treatment and disposal
5. prevent cross contamination of raw materials

• ensure supply water is of potable quality for processing and cleaning and shall meet the WHO guidelines for Drinking Water Quality or other standards specified by regulatory agency
• when purified water…
  – water purification, storage and distribution equipment must be operated to ensure reliable source of water of appropriate chemical and biological purity as define in Schedule B to Food and Drug Act

Question 10

Environment - Continued

Answer 10

• protect…
  1. raw materials
  2. packaging materials
  3. in-process and finished products
• against…
  1. physical
  2. chemical
  3. microbial contamination
  4. deterioration of products and container during storage and temporary storage while in transit
• clearly mark physical quarantine areas
• manufacturers, packagers and labellers must design premises to accommodate hazardous raw material storage and homeopathic processing requirements
• supporting documentation would include floor plan showing location of segregated areas, ventilation and flow of materials thru the site

Question 11

Standard Operating Procedure (SOP)

Answer 11

• detailed, written instructions to achieve uniformity of performance

Question 12

Out of Specification (OOS)

Answer 12

• raw materials, packaging materials, intermediate products, and finished products that do not meet one or more of the requirements defined for that specific item
• specifications above according to regulatory agencies, pharmacopeia, or in-house defined standards

Question 13

Batch

Answer 13

quantity of product in processing stage, homogeneous within specified limits, produced according to single manufacturing order and as attested by signatories to order

Question 14

Define GMP

Answer 14

• quality of concepts and consists of a set of P+P for manufacturers of drug products
• FDA: systems that assure proper design, monitoring, and control of manufacturing processes and facilities; adherence -> ID, strength, quality, and purity of drugs products by requiring manufacturers of meds control manu operations

Question 15

cGMP

Answer 15

• current GMP
• focus on potential risks associated w/ manufacturing of high risk dosage forms (sterile products) and manufacturers w/ prev offense, and implements a consistent approach that involves innovative science based policies
• assures ID, strength, quality and purity of drug products by requiring that manufacturers of meds of adequately control manufacturing operations

Question 16

Key Elements of GMP

Answer 16

1. People involved
2. Environment and equipment
3. Procedures (Operations)
4. Quality Systems (Management)

Question 17

Standard requirements for personnel

Answer 17

Personnel - Training
- education (ongoing GMPs and continuing training)
- practical experience to perform assigned duties
- maintain records of education
Personnel - Hygiene
- personnel have (1) direct contact w/ raw and/or packaging materials, (2)in-process materials and (3) unpackaged products; (4) processing equipment
- practices to protect product against contamination
- Health and hygiene program in writing

Question 18

Standard requirements for Environment

Answer 18

1. size of building
2. building design to facilitate maintenance
3. cleaning and sanitary operations
4. prevent entry of insects and animals
5. facilitate waste treatment and disposal
6. prevent cross-contamination of raw materials
   - ensure supply water quality of both Drinkable (WHO guidelines) and Purified water (Schedule B to Food and Drugs Act)
   – purified water: storage and distribution equipment must be operated to ensure reliable source

Question 19

Key operations and demonstrate factors involved in each operation

Answer 19

SOP- standard operating procedure
- written instruction to achieve uniformity of performance of a specific function
OOS - Out of Specification
- raw materials, packaging materials, intermediate products, + finished
- according to regulatory agencies, pharmacopeia, or in-house defined standards
- Batch - a quantity of product in processing stage
- Lot - quantity of any dosage form, raw material or a packaging material, homogeneous within specified limits, constituting all or part of a single batch and identified by distinct lot number which appears on the label of the finished product
- Quarantine - restriction of availability of material or product for use (physically or by system), until released by the quality assurance person
- raw material - substance, other than in-process product or packaging material
- Master formula - document specifying raw materials with their quantities and packaging materials, detailed description of procedures and precautions required to produce a specified quantity of a finished product

Question 20

Responsibilities of quality units

Answer 20

• health of the public

Question 21

Review processes involved in quality managment