Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

Life science companies need to comply with laws, regulations, and Agency guidance.  Compliance requires understanding processes and technologies and ensuring that quality is built into your process and product.  Compliance means you have the documentation that proves the quality of your product and processes.  When you have compliance issues, you spend your time and your money fixing them, raising your costs and lowering your output.

The figure below shows FDA 483 citations related to various quality and compliance issues.   

®Key compliance issues observed in 2020 include the following.

  • Absence of written procedures and clear SOPs (21 CFR Part 211): This is most observed compliance issue. Specific compliance deficiencies include lack of written procedures, ambiguity with respect to roles and responsibilities assigned, complex language in SOPs, failure to timely update SOPs, and lack of proper description of the steps in the operations.
  • Improper Data Management (21 CFR Part 11): This compliance failure relates to lack of proper data systems that can appropriately use, store, retrieve or archive data efficiently. You need to develop and maintain data management systems that properly manage and control your data.
  • Lack of control procedures (21 CFR Part 211): Another common issues is inadequate control procedures, whether the absence of control of control procedures for batch controls, in-process controls, laboratory controls, labelling control, etc.
  • Inadequate Cleaning, Sanitization, problem of cross contamination (21 CFR Part 211.67): You need to maintain proper procedures for cleaning and sanitization. Inadequate cleaning protocols can be a direct cause of contamination.  You also need to prevent cross contamination from other products or raw materials in production and storage areas and holding areas for active pharmaceutical ingredients, intermediates, finished drug products and container closure systems.

Procedures are just one part of compliance.  Procedures don’t work by themselves.  You need personnel trained for the specific operations.

Companies with strong quality compliant procedures, documentation, and trained personnel consistently achieve the highest compliance to laws, regulations and guidance’s and produce products with the highest quality, safety and efficacy.

PSC Biotech® offers an array of professional services, including Quality Assurance and Compliance Gap Assessment and Remediation, Auditing, Calibration, Technical Writing for procedures and SOPs, and Regulatory Affairs advice.  PSC’s® software solutions such as ACE® (Adaptive Compliance Engine®) and ACE Essentials™ are fully integrated, validated, centralized electronic Quality Management Systems that have been in use by various life- science companies to manage essential aspects of quality systems and ensure compliance.

Call us today to explore the right solution for your needs.

References:

  • 21 CFR (Code of Federal Regulations) Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals), Part 210 (Current Good manufacturing practices in manufacturing, processing, packing and holding of drugs), Part 11 (Electronic Records: Electronic Signatures), Part 820 (Quality System Regulation)
  • Annex 5, World Health Organization, Guidance on good data and record management practices
  • ICH Q7 guideline: Good Manufacturing practices for Active Pharmaceutical Ingredients