GMP Manufacturing

Question 1

GMP stands for

Answer 1

Good manufacturing practise. (c for current)

Question 2

Five values of cGMP for API

Answer 2

Safety •Identity•Strength•Quality•Purity

Question 3

GMP-Definition

Answer 3

“ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to the irintended use and as required by the marketing authorisation or product specification”

Question 4

The ICH stands for

Answer 4

•International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Different regulatory systems were based on the same fundamental obligations:–to evaluate the quality, safety and efficacy of the API’s

Question 5

ICH Q7A

Answer 5

Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients”
43 page common sense guideline–Written by those in the industry–Specific for API’s

Question 6

ICH Q7A Manufacturing defined as

Answer 6

all operation of receipt of materials, production, ackaging, repackaging, labeling, re-labeling, quality control, release, storage and distribution of APIs and related controls.

Question 7

Quality must include:

Phase Appropriateness of Quality Systems

Answer 7

Each batch is to be identified and approved–An independent Quality Unit makes batch disposition–Testing can be performed by areas other than Quality –Systems for testing raw materials, packaging materials, intermediates and APIs are to be in place –Process and quality problems should be evaluated–Labeling should be controlled and identified for investigational use

Question 8

Quality Management [Q7A].

Quality should be the responsibility of

Answer 8

all persons involved in manufacturing.

Question 9

Quality Unit is defined in Q7A

Answer 9

Quality Unit is independent of production
•Fulfills Quality Assurance (QA) responsibilities
•Fulfills Quality Control (QC) responsibilities
–All deviations from approved procedures must be documented; critical deviations must be investigated

–Involved in all quality-related matters
–Review and approve all quality-related documents
–Responsibilities described in writing and not delegated
–Responsibilities for production activities defined
–Internal audit responsibilities
–Annual Product Reviews

Question 10

cGMP Documentation Q7A]

Answer 10

All documents related to the manufacture of intermediates or APIs should be prepared, reviewed, approved and distributed according to written procedures. Such documents can be in paper or electronic form.

Question 11

SOP’s

Answer 11

standard operating proceedure
Written, approved procedures (SOP’s) must be in place for all operations•No operation/matter is “trivial”•Ensuring consistency and minimizes differences in approaches by different personnel

Question 12

cGMP Production

Answer 12

Everything should be traceable–Materials–Equipment–People–Steps –Time
Balances to be verified daily

Question 13

Education and Training Q7A]

Answer 13

There should be an adequate number of personnel qualified by appropriate education, training and/or experience to perform and supervise the manufacture of intermediates and APIs. [

Question 14

Education and Training steps

Answer 14

Each person must be trained to perform the assigned task—regular or temporary
Trainers must have ability and knowledge to train
Responsibilities of each person are to be documented

Question 15

Quality Control

Answer 15

Quality Control is that part of Good Manufacturing Practice which is concerned with sampling, specifications and testing, and with the organisation, documentation and release procedures which:Ensure that the necessary and relevant tests are actually carried out and thatmaterials are not released for use, nor products released for sale or supply, untiltheir quality has been judged to be satisfactory.

Question 16

Quality Assurance

Answer 16

Ensuring that medicinal products are of the quality required for their intended use and in compliance with Marketing Authorisations .A wide-ranging concept, which covers all matters, which individually or collectively influence the quality of a product. It is the sum total of the organised arrangements made with the objective: Quality Assurance therefore incorporates Good Manufacturing Practice plus other factorsoutside the scope of this Guide.