Meeting cGMP regulations with innovative single-use technologies
March 1, 2023
Table of contents
ShowManufacturers in the pharmaceutical industry are required to comply with cGMP (Current Good Manufacturing Practice). For good reason: Taking medicines must be safe for patients. The complex regulations affect many different areas involved in the manufacturing process, such as facilities, equipment, staff, testing, or documentation. But what are ways to comply with cGMP?
End-to-end solutions based on automated single-use technologies are an auspicious choice for drug substance manufacturers given their many advantages. Their implementation in the manufacturing process promises efficiency, high product quality, cost reduction, and energy savings.
Current Good Manufacturing Practice (cGMP) regulations in the pharma industry
Current Good Manufacturing Practice (cGMP) are regulations set by the Food and Drug Administration (FDA) that apply to companies operating in the biopharma industry. According to these requirements, manufacturers must comply with the latest standards in the production of pharmaceuticals. This relates to the planning, monitoring and control of manufacturing processes, equipment, and facilities. Compliance with cGMP assures end-users that drug products meet their quality standards and are safe, pure, and effective.
cGMP compliance implementation: What it takes
In order to adhere with cGMP compliance, the FDA requires drug manufacturers to meet various standards. The regulations are set out in 21 CFR (Code of federal regulations) and are flexible in their implementation. Companies can decide for themselves how to best apply the different processing methods and testing procedures.
cGMP requirements are:
- Buildings and facilities in good condition
- Regularly maintained and calibrated equipment
- Qualified and well-trained staff
- Reliable and reproducible processes
Manufacturers can implement the listed requirements by:
- Developing a strong quality management system
- Procurement of raw materials of appropriate quality
- Establishing robust operating procedures
- Identifying and investing deviations in product quality
- Maintaining reliable testing laboratories
Meeting cGMP regulations with single-use technologies
Implementing fully automated single-use technology in the manufacturing process can help companies to follow the regulations given by the FDA and thus improve their cGMP compliance. Manual processes are replaced by automated technologies and thus fulfill important factors for GMP such as reproducibility, standardization and reduced risk.
Furthermore, a single-use system promises safe storing and transporting during laboratory testing, automated documentation processes and effective and reliable staff processes - everything in line with the CFR Title 21.
Documentation of batch production records and manufacturing processes
One reason why manufacturers often fail to comply with cGMP regulations is an inadequate master manufacturing record and batch record. However, these are crucial for pharmaceutical manufacturing sites as they keep records about the production performance and the quality of a product. According to 21 CFR 11, both records must be stored electronically over a predetermined time. Automated systems can help to streamline such processes by taking over this documentation.
Automated single-use platform systems conduct data such as audit trails, batch reports, performance data, etc. electronically, save it, and communicate with each other, meaning that data is forwarded to the next platform it goes through.
They replace manual documentation and thereby require fewer staff, reduce mistakes to a minimum, and are more time efficient. GMP are interrelated with Good Documentation Practices (GDP), which offer directives for the creation and compilation of all types of documents necessary to satisfy GMP and other regulatory requirements. This guarantees the dependability, authenticity, and accuracy of data obtained throughout the research, development, manufacturing, and testing of drugs and medical devices.
Staff performance & SOPs
To adhere with the cGMP regulations, company employees must follow Standard Operating Procedures (SOP) and be constantly informed of their changes.
This requires experience and appropriate staff training. Automated single-use solutions help to standardize and simplify these processes. Single-use technology increases the scalability and efficiency of manufacturing and also the security for the personnel, where safe handling of bulk drug substance is key.
Fully automated systems also decrease human errors, which can be dangerous and contaminate the quality of the products. This is also one of the core fundamentals of the Good Automated Manufacturing Practice (GAMP), which are guidelines emphasizing that quality should be tested at every stage of the manufacturing process - from raw materials, facility and equipment, to staff training and hygiene. These guidelines offer a dependable framework for pharmaceutical companies to maintain GMP compliance and deliver top-notch products to their end customers.1
cGMP compliant Freeze-Thaw & Fill-Filtration processes
An automated process solution during fluid management, incl. aspetic filling of drug substance, freezing and packaging, help optimize the manufacturing process and comply to cGMP. Thanks to their automated, standardized processes, single-use technologies provide high efficiency, unrestricted scalability and flexibility.
The safe and controlled processes ensure that the drug substances are of high quality and product losses as well as contamination are minimized. And above all, the possibility of storing data electronically, makes single-use technologies compliant with the 21CFR11.
GMP Annex 1 regulations and single-use technologies
GMP Annex 1 is a regulatory guideline that focuses on manufacturing sterile medicinal products. It addresses aseptic processing and contamination control to ensure product safety and quality. One effective solution to meet Annex 1 requirements is the implementation of single-use technology. By utilizing single-use assemblies, companies can enhance sterility and integrity while minimizing the risk of cross-contamination. Single-use technology offers advantages such as reduced cleaning validation, faster changeovers, and improved operational flexibility. It aligns with the principles of Annex 1 by providing a closed system approach for fluid management, promoting product safety, and simplifying compliance with regulatory guidelines.
Conclusion: What is necessary for cGMP compliant manufacturing?
As single-use systems are constantly improving, there are now more compelling reasons for manufacturers to adopt this technology. Striking arguments are time efficiency in terms of the reduced setup time for the processes as well as the ease of scalability. Moreover, single-use technologies are also proven to be more sustainable compared to traditional stainless steel equipment, as they take less time to clean and decrease the risk of contamination and product loss.
Single Use Support does not only offer individual products, but also provides complete end-to-end processes that can be customized to meet the specific needs of each manufacturer. Automated processes are a safe option for companies aiming to not only comply with GMP, but the most current version of it. They are reproducible and standardized, and thus help to minimize human error and enable the processing of substantial quantities of drug substances within a few hours.
- Adherence to the Current Good Manufacturing Practice (CGMP) Regulations in the 21st Century, https://stap1701en.previ3w.com/PDF/cphi_annual_rep_2016_v6_lo_res.pdf#page=4, Published 01.03.2023
