WHO Provides GMP Training to South African Inspectors

Training in Good Manufacturing Practices (GMP) by the World Health
Organization (WHO), to inspectors from the Medicines Regulatory Authority

in South Africa
A two week GMP training workshop was presented by the WHO, to inspectors
from the South African Medicines Regulatory Authority (Medicines Control
Council, (MCC)).
The first week (11 to 15 April 2005) focused on basic GMP

recommendations.
The programme was as follows:
Training Workshop on Good Manufacturing Practices (GMP): Basic principles
South Africa
11 - 15 April 2005.
Monday 11 April
Time Topic Presenter
09h00- Opening - Department of Health, Ministry of Health and Dr JC Gouws
09h30 Medicines Regulatory Authority
Welcome - WHO Representatives
09h30- Introduction of participants All
10h00
10h00- Coffee
10h30
10h30- The concept of quality assurance (QA) and GMP (1, 2) Dr AJ van Zyl
11h30
11h30- Contract production and analysis (7) Mr G Bourdeau
12h30 Sanitation (3) and Hygiene (11)
12h30- Lunch
13h30
13h30- Practical exercise Mr G Bourdeau and
15h00 all
15h00- Tea/coffee
15h30
15h30- Discussion All
16h30
Tuesday 12 April
09h00- Personnel (9) and training (10) Mr G Bourdeau
10h00
10h00- Coffee
10h30
11h30 all
11h30- Materials (14) Dr AJ van Zyl
12h30
12h30- Lunch
13h30
13h30- Practical exercise Dr AJ van Zyl and all
15h00
15h00- Tea/coffee
15h30
16h30
Wednesday 13 April
09h00- Premises (12) Mr G Bourdeau
10h00
10h00- Coffee
10h30
11h30 all
11h30- Equipment (13) Dr AJ van Zyl
12h30
12h30- Lunch
13h30
13h30- Practical exercise Dr AJ van Zyl and all
15h00
15h00- Tea/coffee
15h30
16h30
Thursday 14 April
09h00- Introduction to Validation (4) Dr AJ van Zyl
10h00
10h00- Coffee
10h30
10h30- Documentation (15) Mr G Bourdeau
11h30
11h30- Documentation continued Mr G Bourdeau
12h30
12h30- Lunch
13h30
15h00 all
15h00- Tea/coffee
15h30
16h30
Friday 15 April
10h00
10h00- Coffee
10h30
10h30- Tests, discussion and close All
12h30
12h30- Lunch
13h30
The presentations used, were those from the WHO Basic training material.
Additional hand outs and practical examples were given during the training.
Presenters:
Dr AJ van Zyl
Mr G Bourdeau
List of participants:
Afrika, H
Benade, L
Bonthuys, L
Dangor, C, Prof
Eagles, P, Prof
Gouws, J. C, Dr
Mahlatji, D
Masuku, G
Milne, P, Prof
Mofokeng, K. P
Moropyane, H
Motshitela, E
Nkosi, D
Pule, N
Sehloho, T
Sewram, Prof
Swanepoel, L
Syces, Prof
Taute, E
van der Westhuizen, H
Zulu, M
The second week of training was presented from 27 June to 1 July. It

focused on the WHO Supplementary training modules including Heating,
Ventilation and Air Conditioning (HVAC), Water systems, Validation and
Qualification, and Inspecting the Quality Control Laboratory.
The training focused on practical aspects of inspecting HVAC and water systems.
Examples and practical exercises were given on validation (how to assess
qualification and validation protocols and reports), and how to inspect a quality
control laboratory. The training material of WHO (supplementary modules) was
used as a basis for the preparation of the training, although the presentations
were amended by the presenters (See below).
The programme was as follows:
Training Workshop on Good Manufacturing Practices (GMP): Supplementary training
South Africa
27 June - 1 July 2005.
Monday 27 June
09h00- Opening - Department of Health, Ministry of Health and
09h30 Medicines regulatory Authority
Welcome - WHO Representatives
09h30- Introduction of participants and general introduction to the
10h00 workshop
10h00- Coffee
10h30
10h30- Quality control laboratories Dr AJ van Zyl
11h30
11h30- Quality control laboratories continued, and OOS Dr AJ van Zyl
12h30
12h30- Lunch
13h30
13h30- Practical exercise and case studies All
15h00
15h00- Tea/coffee
15h30
15h30- Discussion
16h30
For the presentation, click here. QC Laboratories
Tuesday 28 June
09h00- Validation: Dr J Pogany
10h00 1. Validation Master Plans
2. Validation of analytical methods
10h00- Coffee
10h30
10h30- Manufacturing and QC equipment: DQ, IQ, OQ Dr J Pogany
11h30
11h30- Manufacturing process validation Dr J Pogany
12h30 a. Prospective validation including quality and capability
of processes as well as identification of critical product
and process variables during development pharmaceutics
including scale up.
b. Concurrent validation (validation protocol and report of
the first three production scale batches)
c. Retrospective validation (annual product review)
12h30- Lunch
13h30
13h30- Cleaning validation Dr J Pogany
15h00
15h00- Tea/coffee
15h30
15h30- Practical exercise, case studies and discussion All
16h30
For the presentation, click here. Validation
Wednesday 29 June
09h00- Introduction to HVAC Mr D Smith
10h00
10h00- Coffee
10h30
10h30- HVAC continued, and sampling booths Mr D Smith
11h30
11h30- Qualification of the HVAC systems and sampling booths Mr D Smith
12h30
12h30- Lunch
13h30
13h30- Practical exercise: Visit to HVAC service area All
15h00
15h00- Tea/coffee
15h30
15h30- Discussion
16h30
For the presentation, click here. HVAC
Thursday 30 June
09h00- Water systems design Dr E Allcock
10h00
10h00- Coffee
10h30
10h30- Water systems continued including qualification, Dr E Allcock
11h30 sanitization
11h30- Practical exercise All
12h30
12h30- Lunch
13h30
13h30- Practical exercise: Water production plant All
15h00
15h00- Tea/coffee
15h30
15h30- Discussion
16h30
For the presentation, click here. Water systems
Friday 1 July
09h00- Case studies and discussion All
10h00
10h00- Coffee
10h30
10h30- Test, discussion and close All
12h30
12h30- Lunch
13h30
Presenters:
Dr AJ van Zyl
Dr J Pogany
Dr E Allcock
Mr D Smith
List of participants:
Afrika, H
Bapoo, R, Dr
Benade, L
Bonthuys, L
Dangor, C, Prof
Dekker, T, Prof
Eagles, P, Prof
Gouws, J. C, Dr
Leng, H, Prof
Mahlatji, D
Masuku, G
Mofokeng, K. P
Moropyane, H
Motshitela, E
Nkosi, D
Pule, N
Sehloho, T
Steenkamp, A
Swanepoel, L
Taute, E
van der Westhuizen, H
Zulu, M

WHO Provides GMP Training to South African Inspectors

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Training in Good Manufacturing Practices (GMP) by the World Health

Organization (WHO), to inspectors from the Medicines Regulatory Authority

The first week (11 to 15 April 2005) focused on basic GMP

The programme was as follows:

Training Workshop on Good Manufacturing Practices (GMP): Basic principles

The second week of training was presented from 27 June to 1 July. It

Training Workshop on Good Manufacturing Practices (GMP): Supplementary training

27 June - 1 July 2005.

For the presentation, click here. QC Laboratories

For the presentation, click here. Validation

For the presentation, click here. HVAC

For the presentation, click here. Water systems

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