Annex 8 – Sampling of Starting and Packaging Material
This very short but important interactive e-Learning / Online GMP training Annex 8 module introduces the user to the GMP regulations relating to the sampling of starting and packaging materials.
The objectives of this training module are:
- to understand personnel training requirements and responsibilities
- to understand the requirements relating to validation of the sampling process
- to understand sampling considerations
The scope of this Online GMP training course on EU and PIC/S GMP Annex 8 covers the critical aspects of sampling, as only a very small fraction of a batch is taken and assumed to be representative of the entire batch.
The training course covers the fact that any conclusions on the whole batch cannot be based on tests which have been carried out on any non-representative samples.
Proper sampling is an essential part of the Quality Control or Quality Assurance system.
The guide talks about the importance of initial and on-going regular training in the disciplines relevant to correct sampling for all staff who are performing the sampling process.
Obviously, the technical training, (not covered in the course) should include:
- sampling plans,
- written sampling procedures,
- the techniques and equipment for sampling,
- the risks of cross-contamination,
- the precautions to be taken with regard to unstable and/or sterile substances,
- the importance of considering the visual appearance of materials, containers and labels
- the importance of recording any unexpected or unusual circumstances.
After successful completion of each course in the bundle the trainee will have the option of printing or saving a personalised training certificate that meets regulatory PIC/S and EU GMP requirements.