Prevention of cross contamination: Contamination is the presence of undesired materials on a surface or fluid, here are some examples of sources of contamination; people, raw materials, air, and water. These should be prevented from occurring as it as a high risk safety effect on patients and it should be considered from design stage. This can be prevented from occurring by implementing, monitoring and following rules which are;
- SOP must be followed at all times.
- Any changes to the SOP must be documented and recorded (GDP).
- SOP must be detailed (should have equipment name and number, type, date approved, revision number, change history if any, process and operation steps, name, etc)
- PPE must be worn at all times.
- No eating or drinking in the production area.
- Only trained and competent personnel should operate on equipment.
- Equipment must be labelled and identified correctly.
- Raw materials must be inspected and testing before and after use.
- Tests must be carried out at each process stages, so as to safe guide cross contamination. If this do happen, it will be easily identified at that stage, when, where and what might have gone wrong.
- After production, equipment must be cleaned properly and tested for cross contamination (GMP).
- Air going in and out of production should be controlled by using filters e.g. HEPA.
- Final product must be tested, to ensure that there are no contaminations in the product.
- Packaging and labelling must be done correctly.
Validation: Is the documented act of demonstrating that an activity will consistently lead to the expected results while meeting regulatory requirements. It requires a minimum of 3 batches to run simultaneously with an error. If an error occurs at anytime, validation is void and another 3 batches must be carried out. With new cGMP, just 3 batches is not enough, a system or process should show consistently that the process or system is continuously within validation specification.
The above diagram shows the documentation that should be referenced to when generating qualification protocols.
- URS - Is a document that outlines a company’s specific requirements for a system or equipment they wish to purchase. This document contains the followings (overview of the process, process impact, operational, hardware and software, P&ID, training and EHS requirements and vendor deliverables).
- FS - This is a detailed document on how the vendor is going to meet the specific requirements of the URS. This can also include price and conditions of supply.
- DQ - This is a comparison of the detailed URS with the functional specification and we can determine if there are any gaps in the proposed system elements detailed by the vendor and the risk can be evaluated.
- FAT - Confirms the suitability of the system or equipment prior to delivery to the company, should include well documented testing, acceptance criteria and mechanisms for disaster recovery testing and...