Earlier I have shared you the GMP Requirement for Pharmaceutical plant premises, Equipment’s and Production. There are various modules of GMP which I will share one after another & today’s module is Training and personnel Hygiene.
Training:
Training is the main aspects of Good Manufacturing practices and whenever a person joins in an organization he/she required to take the training which includes GMP, Good Documentation practices and job related training etc.
For GDP pl Refer : https://pharmaceuticalupdates.com/2019/01/06/scope-instruction-to-be-followed-for-good-documentation-practices-gdp-in-pharmaceuticals/
The Organization should provide training with a written programme for all personnel those who are going to work in Production, Quality Assurance, Quality control, Engineering and warehouse departments (including the technical, maintenance and cleaning personnel).
Different types of the training are there which includes Induction Training, on job Training, Self Reading Training, External training and Refresher Training etc.
Training shall be conducted as per training Standard Operating Procedure of the respective organization.
For SOP Please Refer : https://pharmaceuticalupdates.com/2019/02/02/standard-operating-procedure-sop-of-standard-operating-procedure-sop/
Besides basic training on the theory and practice of GMP, newly recruited personnel should taken training accordingly to their job responsibilities assigned to them. Training should also be given at a regular interval and as per scheduled and its practical effectiveness to be assessed periodically.
After completion of required training evaluation shall be done and based on evaluation the person can be eligible to perform his/her job responsibility and training record required to be maintained. Personnel working in areas where contamination is a hazard, e.g. clean areas or areas where highly active, toxic, Hormones, infectious or sensitizing materials are handled, should be given specific training i.e. Entry and Exit to production area, Uses of Personnel protective Equipments and personnel hygiene etc.
Visitors or untrained personnel should preferably not be taken into the production and QC areas. If this is unavoidable, they should be given relevant information in advance (particularly about personal hygiene) and the prescribed protective clothing. They should be closely supervised by the plant personnel.
Consultant and contract staff or casuals should be qualified or trained for the services they provide. Evidence of this should be included in the training records.
Personal Hygiene:
All personnel should undergo health examinations prior to and during employment.
Personnel conducting visual inspections should also undergo periodic eye examinations.
All personnel should be trained in the practices of personal hygiene. A high level of personal hygiene should be observed by all those concerned with manufacturing and packing processes. Personnel should be instructed to wash their hands before entering production areas.
Any person shown at any time to have an apparent illness or open lesions that may adversely affect the quality of products should not be allowed to handle starting materials, packaging materials, in-process materials or medicines until the condition is no longer judged to be a risk.
All employees should be instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that they consider may adversely affect the products.
Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.
To ensure protection of the product from contamination, personnel should wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, should be stored in separate closed containers until properly laundered and if necessary, disinfected or sterilized.
Smoking, eating, drinking, chewing, and keeping plants, food, drink, smoking material and personal medicines should not be permitted in production, laboratory and storage areas, or in any other areas where they might adversely influence product quality. Personal hygiene procedures, including the wearing of protective clothing, should apply to all persons entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors’ employees, visitors, senior managers and inspectors.
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