Author: Kia Kahhali, founder and CEO, APS Compliance Consultants Inc.
This is the first of three articles, highlighting the GMP compliance problems often seen within the maintenance departments of pharmaceutical operations, that can be addressed with integration of an adequate CMMS. It also reveals the challenges of integrating CMMS in Pharmaceutical industry that defines the key parameters for selection of a suitable system.
PARTICULARITIES OF MAINTENANCE IN THE PHARMACEUTICAL INDUSTRIES
Unlike many other industries, managing Preventive Maintenance in the pharmaceutical industry has its own particular importance as the several pieces of equipment distributed between utilities, production and laboratories and their maintenance are subject to much higher standards than in other sectors.
To guarantee the quality and conformity of medicinal products, the production must comply with the Current Good Manufacturing Practices (cGMP). The main principles of cGMP explicitly mention the importance of quality of equipment maintenance.
Without going to many details, the main cGMP principles related to our discussion are as follows:
- Keep a written record of operating procedures and instructions to provide a roadmap for GMP compliance and consistent quality production.
- Meticulously follow procedures and instructions to prevent contamination, reworks, or error.
- Taking Contemporaneous and accurate note of ongoing tasks for procedural compliance and traceability purposes.
- Demonstrate that systems are doing what they were intended to do by conducting formal validation and/or qualification processes.
- Carry out the maintenance of buildings and equipment in a regular and efficient manner.
- Protect products from contamination by adopting regular and systematic habits of cleanliness and hygiene.
- Implement quality controls to check raw materials and processes such as manufacturing, packaging, labelling, etc.
- Plan and conduct regular audits to ensure GMP compliance and quality system effectiveness.
Since the slightest deviation from the rules during manufacture can have serious consequences for patients. Therefore, the controls and checks imposed on pharmaceutical plants are much more rigorous and more frequently audited than the ones in other sectors.
For example: a maintenance order must be issued before any work is performed. It must contain a lot of information such as the name of the equipment, the description of the work to be done, the name of the person executing the task, etc. At the end of the intervention, the work order must be completed by specifying any modifications made, the products used and the parts that have been changed, and the functional tests that performed to ensure the equipment is working as expected.
Finally, it may or may not require further approvals and signatures prior to equipment be authorized to back in service. The closed work orders be archived and remain accessible for future consultation in case of investigations and audit inquiries.
The particularity of the sector implies more than technical and managerial skills to establish and run a performant maintenance department in pharmaceuticals. The regulatory and conformity aspects of the task are at least as important as its technical aspects and introduce new challenges that can not be left unaddressed.
Now that you have a taste of the extra requirements applying to the sector, comes the top GMP Maintenance challenges. The second part of this article “GMP claiming problems facing maintenance departments of pharmaceutical operations”.
ABOUT THE AUTHOR
Kia Kahhali is the founder and CEO of APS Compliance Consultants Inc.
For Corresponding, contact kkahhali@apsinco.com
With over 20 years of experience in the Pharma industry, Kia has accomplished to build himself a unique profile. This was achieved by tying his electronics engineering and software development background to GMP Computer System Validation and Analytical Instrument Qualification and Management.
With the technical and regulatory knowledge of risk-based equipment and system lifecycle management, business processes, and successful industry records, he is actively working as a reliable resource for many companies looking for selection, Installation/implementation, maintenance and validation of their equipment and systems