Are you ready to introduce a new process equipment into a production line with validated cleaning effectiveness?
The answers to the following questions will help assess the readiness to introduce new equipment into the pharmaceutical manufacturing area and identify the scope of GMP-related activities required in this process:
- Are the critical surfaces of the new equipment, including auxiliary devices and utilities, identified?
- Is information available on the materials that come into direct contact with the product?
- Has the surface area of the new equipment and auxiliary devices been correctly calculated?
- Have sampling points and methods for chemical and microbiological cleanliness testing been selected?
- Will the surface area of production lines change?
- Will the limits for API residues after cleaning change?
- Do the new limits impact the status of completed cleaning validations?
- Has the equipment manufacturer provided documentation with a proposed cleaning methodology?
- Have cleaning methods for the new equipment been developed and preliminarily tested?
- Is a new API to be introduced into the manufacturing area?
- Could the new API represent a new worst-case scenario or change the residue limits of other APIs?
- Does the manufacturer possess a complete set of toxicological reports for all APIs used in the facility?
- Are validation activities planned and carried out using risk management methodologies?
- Are the analytical methods used to detect API residues after cleaning validated within the ranges that reflect established limits?
- Are microbiological cleanliness testing methods validated?
- Are methods for detecting detergent residues validated?
- Is the personnel trained in cleaning instructions, sampling, and performing analyses?
- Are cleaning validation plans, protocols, and reports developed?
- Is monitoring conducted to confirm the effectiveness of validated cleaning procedures?
The answers to these questions should be known to specialists in the pharmaceutical manufacturing facility responsible for implementing new equipment within the GMP framework. They may also be raised during an audit or a regulatory inspection.
We are ready to support you in finding the answers, documenting them, and integrating them into the Pharmaceutical Quality System – as the eLife Sciences team.
Grzegorz Suwała
Senior Validation Specialist
