Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®
Quality lies at the heart of every pharmaceutical process. You build quality into your product! Current Good Manufacturing Practices (cGMPs) are the minimum legal requirements to assure the quality of your pharmaceutical product. While companies can test the final product to check for quality specifications, testing is just a check and does not substitute for quality is built into every step of the process.
You can’t test a Volkswagen into a Cadillac! If you want to build a Cadillac you plan, design, and build a Cadillac. You manufacture your quality pharmaceutical product by building quality into every stage of the product life cycle, from the R&D stage through the manufacturing, storage and distribution until the product reaches the end user. When you build quality in, you get quality products out of your process.
The ICH Q7 guideline
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was founded by three Regulatory Agencies with the objective of harmonizing standards and regulations across countries and ensure consistency of the drug product and reduce duplication of efforts. Today, ICH guidelines are one of the most widely followed guidelines and accepted in many countries.
The ICH Q7 guideline focuses on how cGMP practices can be implemented for the manufacturing of Active Pharmaceutical Ingredient (API) or the active drug substance. While ICH Q7 formally applies to manufacturing of APIs, ICH Q7 can also be a good starting point for companies manufacturing any kind of product to bring cGMPs into their processes.
Key elements of ICH Q7 include:
1. Quality Management System: Companies need to establish quality units responsible for ensuring quality, developing and monitoring production activities as well as performing periodic internal audits and quality reviews.
2. Personnel: Your personnel need appropriate training, education, and experience to do their assigned jobs. You need to document personnel training.
3. Buildings and Facilities: You need proper buildings, equipment, and utilities. You need to validate and maintain your physical assets.
4. Process Equipment: You need to ensure that all your equipment is designed as per required specifications, that they are cleaned and maintained properly, as well as calibrated, validated, and periodically revalidated.
5. Documentation and Records: In the life-science industry “If it isn’t documented, it didn’t happen”. Good Documentation Practices (GDP) are how you prove it happened. You need to ensure all processes are documented clearly in simple language and indicate the latest practices, retain documents, and establish electronic database systems that can maintain an audit trail, track changes and deviations to aid in inspections.
6. Materials Management: You need procedures for receipt, identification of materials as well as their storage, handling, sampling, testing and rejection.
7. Production and Process Controls: You need in-process controls, acceptance criteria, contamination controls, etc.
8. Packaging and Labeling: You need procedures and controls for Packaging and Labeling materials and operations.
9. Storage and Distribution: You need procedures and controls for storage, shipping, and distribution. If you had to recall the product, does your system tell you quickly where it went? Do you test your systems?
While this is not an exhaustive list of CGMP systems and processes you need, consult ICH Q7 Guideline at https://www.ich.org/page/quality-guidelines as well as your local Regulatory Agency’s laws, regulations, and guidance documents.
PSC Biotech® offers professional services such as Quality Assurance and Support, Commissioning and Decommissioning services, Validation services, Regulatory Affairs support, Audit functions as well as Engineering support that can help your company implement the latest cGMPs for your processes to meet ICH and all the other regulations you have to comply with.
Contact us today if you need support with any of these services to help you accelerate your success!