GMP audit of any industry is quite an important process and significant in terms of the overall business. Therefore, proper preparations for the GMP audit should be carried out before the main audit. Let us help you know the importance of GMP auditing service in the pharmaceutical industry.
Preparing for GMP Auditing and Inspections
Making sure that you have full control over the respective facility, processes, and QMS (Quality Management System), and the overall product quality, is an important and challenging task. One way to ensure the same is through reliable services from professional GMP audit companies in the pharmaceutical industry.
If you wish to prepare a detailed pharma audit report, here are some aspects to look into:
- Review Documents: This is a list of all related documents for the auditing process. Such documents in a detailed GMP audit report can include batch manufacturing records, standard operating procedures, master formula records, change controls, deviations, the process of analysis, and so more.
These documents are helpful in reviewing the completion, updates, overwriting, and correctness aspects of the GMP audit process.
- Preparation of the GMP Audit Plan: A dedicated plan for a GMP audit should be prepared before the commencement of the audit. It helps in showing the overall flow of the audit. In this process, the strength of every step is analyzed and eventually shown to the auditor. It is important to note the strongest and the weakest aspects of the departments before the audit.
- Analyzing Key People: One or two individuals having detailed knowledge about the relevant documents and subsequent systems of every department should be selected as key people of the organization. These people should be responsible for explaining everything related to the pharma department to the auditors.
- Understanding Audit Responsibilities: The overall work and areas should be allotted to every member of the pharma department. Everyone will be responsible for the correctness and completion of the work that has been allotted. Moreover, the head of the pharma department should make sure that the work is completed before the main audit.
- Executing Internal Audits: Internal audits are expected to be conducted before the main audit. It helps in ensuring that proper GMP audit preparations have been carried out. It will also help in increasing the overall confidence level of the people involved in the audit. Internal audits serve to be the foundations of a successful GMP audit.
If you wish to make any GMP audit in the pharma industry successful, here are some important points to note down. Audits are regarded as fundamental blocks of ensuring supplier management systems in the pharma industry. Internal audits serve to be key steps for identifying any relevant gaps in the quality systems or processes. Therefore, in-depth preparation in advance is a great step towards assisting and conducting consistent GMP audits in a proper manner. It will also help in addressing important items required for meeting the GMP specifications.