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Schedule M series - Training

Training:

Training is one of the important aspect in pharmaceutical industry. 

Training are broadly categories as below:

1. Induction training 

2. SOP training 

3. On-job training and

4. Training on Regularly & other soft skills.

Training is covered in all the cGMP guidance and auditors verify the person involved in manufacturing of drug product are well trained to execute his/her task.

Schedule M also emphasized the importance of training hence, covered the following requirement on training.

1.1: Beside basic training on the theory and practice of GMP, newly appointed personal shall receive training to the duties assigned to them.

1.2: Company should provide training in accordance with a written training program for all personal whose duties take them into manufacturing area or QC. This training includes all the personal from the technical, maintenance and cleaning (house keeping) and for other personnel as required.

1.3: Continues training shall the provided and effectiveness of the training shall be assessed on periodic basis. Training record shall be kept.

1.4: Specific training shall be delivered to the personal working in area where contamination is a hazard.

1.5: Preferably Visitors and untrained personnel shall not allow to be taken into production and quality control areas.

If unavoidable, they shall be given relevant information in advance and the prescribed protective clothing.

1.6: The contract staff and consultant shall be qualified for the services they provide. Evidence of this shall be included in training records.

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Location: Ahmedabad, Gujarat, India

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