- Line clearance should be performed as per SOP & check list and recorded.
- Check for absence of any starting materials, products, product residues, documents of previous product.
- Wherever possible adopt “Closed system” while handling materials.
- Processing of only one material at a time in same cubicle.
- At every stage of processing product, material, printing material should be free from microbial and other contaminants.
- Reduce bio burden and other contaminants by removing outer wrapping of the packaging material in which they are delivered before being issued on the shop floor.
- Containers for filling should be cleaned before use .
- Packaging operations in packing area should be carried out with physical segregation between packing lines.
- Proper validated systems.
- Product and product contact parts of equipment should not be directly handled with bare hands.
- In process control may be carried out in production area, provided they do not carry any risk for the product.
- Campaign production should be followed by appropriate cleaning in accordance with a validated cleaning procedure.
- Materials e.g. lubricants, inks, cleaning fluids should be in containers that look distinctively different from the containers which are used in production and should be labelled as per their content.
- Products that have been involved in an unusual event during packaging should be re introduced into the process only after inspection investigation and approval by authorized personnel. Detailed records should be kept of this operation. Repairs and maintenance operations should not present any hazard to the quality of the products.
- Clothing and its quality should be appropriate for the process and the grade of the working area.
- Linen is non shredding type. (Non linting)
- Minimise exposed body surfaces.
- Wash routinely.
- Separate washing for clothes worn during handling of sensitive products.
- Should not get contaminated by cleaning agents.
- Appropriate personnel protective equipment (PPE) should be used where applicable.
- Dedicated PPE for beta-lactum products, antibiotics, hormones, cytotoxic, drugs manufactured from live micro- organisms.
- Clothing / linen should be changed after every product change over/ breaks.
- Procedure for cleaning foot wear should be available.
- Routine environmental monitoring by particle count, active air sampling and settle plate count to be carried out.
- Capable of repeated wear, laundering without deterioration.
Utilities and Service
- Water used in the manufacture of Pharmaceutical Products should be suitable for the intended use.
- (Chemical & Microbial limits should be appropriate for its intended use)
- free of additives.
- clean steam generators may be used wherever applicable.
- Air to be passed through appropriate filter
- A high level of sanitation & hygiene should be practice in every aspect of the manufacture of drug product.
- Materials used for the operations such as cleaning, lubrication of equipment, pest control, should not come in direct contact with the product. Suitable grade to be used to minimise the health risk.
- Measure to prevent cross contamination and their effectiveness should be checked
- periodically as per procedure.
- Beta lactum products, antibiotics, hormones, cytotoxic, primary packing in dedicated area
- Active raw material of Beta lactum may be transported with other packed active materials and excipients. The packed finished products of these drugs can be transported with other non active finished products.
- In case of spillage or contamination during transport, entire quantity to be rejected.
- All containers of raw materials, in process materials, processed or partially processed, partially packed, finished products to be properly labeled with product name, Batch no., status etc.
- "Cleaned" or "To be cleaned" label should be affixed on empty containers, with names of the previous product.
- Beta-lactum products, antibiotics, hormones, cytotoxic if in the same building, precautions must be taken to avoid cross contamination.
- § Segregated facility
- § Dedicated equipment
- § Use of air extraction and air locks wherever appropriate.
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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