Keeping current with constantly changing regulations can be challenging. In some cases, pharmaceutical companies may find that their practices are not compliant with current guidelines and that remediation measures are necessary.
As such, pharmaceutical companies should understand how to develop effective remediation projects.
A remediation project is designed to rectify issues of manufacturing, laboratory practices, and other processes that do not comply with the regulations.
Sometimes remediation projects result from a review of practices against regulations. At other times, a remediation project is enacted in response to an FDA-483 observation or a Warning Letter ( issued by the Food and Drug Administration. In the letter, the Food and Drug Administration states the violations found during a recent inspection.
They also state that that the pharmaceutical company has ten working days to respond and thirty days to submit a remediation plan.
If no warning letter is involved, the first step in a remediation process is to determine the standards. This could include looking at appropriate regulations such as the International Conference on Harmonisation E10.
The next step is to investigate the chain of supply to determine whether the supply process is sound. In order for a process to be effective, appropriate quality assurance measures should be integrated throughout it. Effective standard operating procedures should be written for it, and appropriate descriptions should be available.
The next step is to determine what the gaps in the process are and set appropriate priorities. If a warning letter is involved, these gaps should be discussed in the warning letter. If no warning letter is involved, these gaps should come from a comparison of the processes with the regulations. These gaps could include inadequate training of professionals and lack of compliance with Good Manufacturing Practices.
Next pharmaceutical executives should discuss their findings with manufacturing personnel, suppliers, personnel responsible for distributing the pharmaceutical, and external remediation experts as appropriate. Their disclosure should be as clear and honest as possible. They should also ask for feedback from these personnel.
On the basis of the findings, pharmaceutical executives should develop a draft plan to rectify the issues. The Food and Drug Administration should also find the plan acceptable. The plan should include a description of important raw materials and a profile of the quality of the raw materials.
The plan may also require pharmaceutical companies to develop effective quality systems, and processes; validate information technology systems, manufacturing processes, laboratory processes, and equipment; and audit supplier systems and processes.
If a warning letter is involved, the nature of the plan may vary. However, the violations could include inadequate training of professionals, incorrect company policies regarding quality management systems, information technology infrastructure, manufacturing systems and equipment, and issues with supplier systems and processes.
In those cases, trainings could involve training of staff in new procedures, awareness training on how to interact during an audit, and development to new standard operating procedures and processes. Changes to management in an organization may also be necessary.
On the basis of the draft plan, the pharmaceutical executive and other members of management develop a final plan. This could include developing a questionnaire on the raw materials and conducting audits of the appropriate sites. Pharmaceutical executives should ensure that documentation designed to assess the products involved and data to support the changes is collected. They should make certain that they have the commitment of the appropriate personnel to implement the changes.
Pharmaceutical executives should then monitor and finalize the plan. If a warning letter is involved, pharmaceutical executives should respond to the letter. Management should have someone in their quality department write up the letter and have other members in management review the letter.
One thing that is important is to provide a realistic timeline for implementation of changes. They should submit the full plan to the Food and Drug Administration within thirty days of receipt of the warning letter. They should then continue implementing the changes and update the Food and Drug Administration of their progress every thirty days.
By developing effective remediation projects, pharmaceutical executives can bring a company’s practices and products with the current guidelines. This results in increased safety to products and ultimately to the patients.
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