Cross-contamination should be avoided by taking appropriate technical or organizational measures.
Measures to prevent cross-contamination and their effectiveness should be checked periodically.
Premises
Design of building
• Reduce or eliminate risks by good design of facilities and services should be equipped with maximum protection against the entry of insects, birds or other pests.
• Entry of unauthorized person should be prevented in the area of production, packing, QC. Persons who do not work in these areas should not use them as the passageway.
• To minimise the risk of medical hazard due to cross-contamination, dedicated and self-contained facilities should be available for particular medicinal products e.g. beta lactum products, antibiotics, hormones, cytotoxic, drugs manufactured from live microorganisms.
• Adequate in-process storage area to minimize the risk of mix up between different products or their components. Orderly placing and logical positioning of equipment and materials.
• Manufacture of sterile products in clean/aseptic areas
• Entry of materials through separate airlocks.
• Interior surfaces e.g. walls, floors, ceiling should be
- smooth
- free from cracks and open joints
- should not shed particulate matter
- should permit easy and effective cleaning.
• Pipework, ventilation and light points and other services should be designed to avoid creation of recesses which are difficult to clean.
• Adopt closed system during manufacturing
• Identify packing line with Batch Number. Only one pack size of a product online.
• Appropriately designed airlocks, pressure differentials air supply and extraction system to be provided.
• QC labs. Analysing beta-lactum antibiotics, hormones, cytotoxic drugs should take precautions especially when they are handled in powder form.
• Accessories should be either dedicated or disposable type.
• Weighing of materials one at a time under Reverse Laminar Air Flow units
• Periodic environmental monitoring of area where susceptible products are processed.
• Materials issued for beta-lactum products, antibiotics, hormones, cytotoxic, drugs manufactured from live microorganisms should not go back to stores or other manufacturing areas.
Equipment
• Install in such a way that any risk of contamination is prevented.
• Should have smooth surfaces free from pitting
• Contact surfaces should be inert, should not be additive or absorptive
• Easy to clean
• Vacuum cleaners to be fitted with appropriate dust retaining filters.
• Dedicated vacuum cleaners for beta-lactum products, antibiotics, hormones, cytotoxic, drugs manufactured from live microorganisms. Filter bags to be disposed off separately with appropriate suitable techniques.
• When two or more similar machines are available in the area for some purpose then,
- maintain separate usage log
- the same product should be handled on different equipment in the area
• Labels on pipelines to indicate the correct direction of flow.
• Use dedicated equipment which is difficult to clean e.g. finger bags, suspension hose, hose pipes, biological or high potency products.
• Water distribution pipelines should have sanitary couplings, the slope for drainage, positive pressure at the point of use to avoid suck back of air.
• Equipment should be kept in good condition and records of maintenance should be kept.
• Clean production equipment thoroughly on a scheduled basis as per SOP and wrap with fresh polythene bags until use.
• Cleaning equipment/cleaning aids that shed particles, raise dust or generate contamination should not be used. Use of bristles, brushes, fiber, shedding clothes to be avoided.
• The sequence of washing, cleaning and drying operation should be designed so as to prevent cross-contamination.
• Remove defective equipment and label it “Defective equipment not to be used”
• Clean common equipment according to validated cleaning procedure during the production of different products.
• Maintain dedicated trolley in each department, production site. Clean the trolley and its wheels before taking from one area to another.
• Systems with microprocessors based application have valves and actuation devices. These should be programmed, challenged and validated to eliminate exposure of one product with another or foreign materials through control failures. Validate this equipment to ensure that they function properly.
• Equipment seals
- On rotating shafts e.g. agitators, pumps, compressors should not come in contacts with products.
- If unavoidable then seal lubricant should be of food grade.
People
• All personnel, prior to and during employment as appropriate, should undergo a health examination.
• A high-level personal hygiene should be observed.
• All personnel should be aware of the principle of GMP that affect them.
• Receive initial and continuing training, including hygiene instructions.
• Direct contact should be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.
• Personnel should wear clean body coverings appropriate to the duties they perform.
• Should apply to all persons entering production areas, whether they are temporary or full-time employees or non-employees.
Contamination risks from people can be reduced by;
• Training
• Understanding the principle of GMP
• Appreciate requirements for cleanliness, hygiene, control of entry.
No comments:
Post a Comment
Please don't spam. Comments having links would not be published.