Writing a Validation Protocol: What we Need to Know
Introduction
For a pharmaceutical industry proving a protocol is a crucial undertaking as it helps determine safety and efficacy of products out in the market. A validation protocol is a defined documented approach towards any aspect of pharma product or process like how its manufactured, tested, packed, labeled or distributed. It can be defined as “It is a process and; in this point processes of validation ensure that the pharmaceutical products produced by the organization fulfill the specified and standard specifications and conform to the standards and regulatory authorities required”. Validation protocols in the pharmaceutical industry, therefore must be fully comprehensive, detailed, and well laid outs. They should encapsulate all that is required by a particular process or product in order to ensure that the results are consistent and repeatable.
The following steps will help you write an effective validation protocol for a pharmaceutical product or process:
1. Understand the scope and purpose of the validation protocol:
A general aim of validation development consists of determining its aims and goals, the key parameters and the scope of validation.
2. Define the validation protocol’s objectives:.
The goals of the protocol need to be defined very much like a set of guidelines with reference to what is to be validated, why it has to be validated and what should be expected as the result of validation. Specific, Measurable, Achievable, Relevant and Timebound—these are the characteristics of the objectives.
3. Establish a validation team:
The formation and implementation of the validation protocol should be accomplished by a dynamic and competent inter-disciplinary team. The team staff usually comprises members of quality control and inspection, manufacturing, and research and development.
4. Outline the protocol’s scope:
The different areas of the protocol should embrace all the pertinent steps or characteristic of the process or product under validation. The diamond model will also be useful for checking what elements are to be included and which is missing.
5. Develop a risk assessment:
From the risk analysis, you shall be able to see the risks that may be likely to occur in the process or product and this shall enable you organize the validation activities from the view of risks that are most likely to occur. This will assist in helping to validate those aspects of the process or product, which are most significant.
6. Define validation acceptance criteria:
The acceptance criteria should be set when the development a protocol for a clinical trial is being laid down. These will define the success or failure of the validation process, and; should be Specified, measured against, and documented against pre-determined specifications, quality parameters/standards or regulatory requirements.
7. Define the validation methods and procedures:
The validation protocol should describe how such validation of the process or product should be performed. They should be evidence based, replicable and fit for intended uses.
8. Plan the validation schedule:
There should be a clear time frame that the validation activities should cover depending on each phase of the validation. This will assist by increasing chances of meeting the set time limit for the validation process.
9. Execute the validation:
After the validation protocol has been developed, it is expected that the validation protocol should be run as planned. This will include, following laid down procedures, processes and protocols, and record keeping.
10. Analyze and report the validation results:
It is recommended that the obtained validation results have to be used to quantify the degree of adherence to the acceptance criteria. A report on the validation should be created and should contain the details of the results of the validation, in addition to all the variances to the validation protocol, and all possible modifications made.
11. Review and approve the validation protocol:
After the validation report has been produced the validation protocol should then be reviewed by the members of the validation team and other relevant departments of the company that may include quality assurance and the regulatory affairs department . We should be able to change or improve wherever needed, and the protocol developed has to be approved before it is implemented.
12. Implement the validated process and monitor its performance:
After the validation has been further streamlined through an approval protocol, it is necessary to use the validated process for performing its function, as well as for continuously monitoring its efficiency to ensure it provides the necessary specifications, comparable quality, and meets legal requirements.
13. Perform ongoing validation maintenance:
That means the first level of validation should include a protocol for validation maintenance to be done periodically to check whether the validated process remains in control. This will include conducting a validation audit, a validation review, which will be followed by other review activities whenever there will be a need to update the validation protocol.
Conclusion
Therefore, the creation of a validation protocol in a pharmaceutical industry is a structural and systematic process. This explains why it is necessary to put down the overall objective of the validation, select a validation team, define the scope of the protocol, assess the risks of validation, and define validation acceptance features. The validation method used should be scientifically reasonable based on the application intended use and there should be a plan as when to effect the validation. After performing the validation, it will be important to assess and document the validation process, and assess and accept the validation protocol. Last, it is necessary to put in practice the activity, the performance of which was considered during validation, control its performance, and continuously update validation to confirm that a product or a process conforms to the requirements and specifications set, complies with the required quality and generates the expected output and corresponds to the legal provisions. If you want to ensure the quality and safety of your pharmaceutical products, here are the steps you have to make when developing a validation protocol.