On-site GMP pharmaceutical supplier audit is a commonly used way to make evaluation and qualification of suppliers in botanical and chemical industries. We herbinspection summarize the general process and shared them with you.
The purpose of GMP pharmaceutical supplier audit
The aim of such a auditing is to make sure the suppliers have implemented with a good management system and obtain the ability to supply qualified products sustainably.
Scope of GMP pharmaceutical supplier audit
With 10 years of supplier auditing experiences,we’ve processed supplier auditing and manage many clients’ Chinese supply chain.We take guidelines of Q7A-GMP for APIs as basis of auditing, and focus on following scopes of your suppliers like:
-Quantity management system
-Buildings and facilities
-Equipments for process
-Documentation and record
-Production and in-process control
-Packing and identification labeling
-Storage and distribution
-Rejection and re-use
-Complaints and recalls
Normally, we will make manufacturer site visiting based on instructions of our clients to have an overall auditing of Chinese supplier’s facilities and documentations, to ensure the facilities are able to match the requirements of subscribed production and the documentation and management system are completed.
Flow chat of GMP pharmaceutical supplier audit
The flow chart of Herbinspection’s auditing is as follows:
1. Brief meeting with suppliers at the site, and check some basic documents that provided by supplies including: Organization Chart; Company Layout; Management system procedure and Process flow chart.
1). Checking the warehouse, pay attention to the storage condition, labeling and analysis status.
2). Visiting the production plant. Check each production step, and supplier’s batch record, equipments, in-process controls, purify water system.Pay specially attention to the re-crystallization, drying and packing rooms and procedures.
3). Quality control department should have required SOPs for all activities, and make sure every equipments been calibrated regularly. We will pay attention to its analysis situations of raw materials, intermediates and Final products. Besides this, all the analysis and calibration should be recorded. Data integrity needs to be maintained.
3. Back to meeting office to check all the related documents like
1)Annual quantity review
2)Personal training and record
6)Corrective and preventive action
7)Calibration and record
9)Retention samples and stability testing and record
4.Close meeting to share with suppliers the deficiencies. Below chart if the major deficiencies we found in the supplier audit
5.Prepare and send audit report to clients
6.Help suppliers to make CAPA report and corrective actions if necessary.
Above process is not only for pharmaceutical, but also for botanical industry.
We’ll keep on sharing our experience and knowledge about GMP supplier audit in systematic sequence. A new post will be released within 1 week. Please sign up our free newsletter to receive the new posts.
Written by Amy Yang
Amy specializes in botanical industry.
With 8+ year’s experience of global sourcing and supply chain management, she got knowledge of herbal extracts,natural ingredients, inspection skills, GMP and suppliers management.
Amy is constantly sharing her knowledge by posts.
She always expects to receive feedback from you.