Controlled Copy in GMP (Good Manufacturing Practice)
Definition
A Controlled Copy is an officially issued version of a document that is managed under a document control system to ensure that only the most current and approved version is in use. In the context of Good Manufacturing Practice (GMP), controlled copies are critical for maintaining compliance, traceability, and consistency across regulated processes and documentation.
Controlled copies are typically distributed with unique identifiers and tracking mechanisms to prevent the use of outdated or unauthorized documents, especially in GMP-regulated environments such as pharmaceutical manufacturing, biotechnology, and medical device production.
Detailed Explanation
Purpose and Importance of Controlled Copies
Controlled copies play a vital role in document control systems within GMP environments. Their primary purpose is to ensure that only the latest, approved versions of documents—such as Standard Operating Procedures (SOPs), batch records, and validation protocols—are accessible and used by personnel. This is essential for:
- Ensuring regulatory compliance with standards such as FDA 21 CFR Part 11, EU GMP, and ICH Q10.
- Preventing errors caused by outdated or incorrect documentation.
- Maintaining data integrity and traceability throughout the product lifecycle.
- Facilitating audits and inspections by demonstrating control over critical documents.
How Controlled Copies Work
Document control systems—either manual or electronic (e.g., EDMS or QMS)—are responsible for managing controlled copies. Here’s how the process typically works:
- A document is created, reviewed, and approved by authorized personnel.
- Once approved, controlled copies are printed or electronically distributed with identifiers such as version number, copy number, and distribution log.
- Each controlled copy is tracked to ensure accountability and retrieval when a document is revised or retired.
- Obsolete copies are either destroyed or archived with proper documentation.
Examples in GMP Environments
In GMP-regulated industries, controlled copies are used in various contexts, such as:
- Standard Operating Procedures (SOPs): Ensuring that only the current SOP is used during manufacturing or testing processes.
- Batch Manufacturing Records: Distributing controlled copies to production teams to ensure consistency in batch production.
- Validation Protocols: Issuing controlled documents for equipment qualification or process validation activities.
Controlled vs. Uncontrolled Copies
A controlled copy is tracked and managed, while an uncontrolled copy is typically for reference use only and not used for official operations. Uncontrolled copies must be clearly marked (e.g., “Uncontrolled when printed”) to prevent misuse.
Best Practices for Managing Controlled Copies
- Implement a centralized document control system (manual or electronic).
- Ensure all copies are logged, numbered, and issued only by authorized personnel.
- Train staff on the importance of using only controlled copies for GMP activities.
- Regularly audit document control practices to ensure compliance.
- Use watermarks, stamps, or barcodes to distinguish controlled copies.
