Validating cleaning procedures in biopharmaceutical manufacturing facilities

Apart from being a core aspect of current Good Manufacturing Practice (c GMP) and Good Validation Cleaning Practice (GVCP) in the pharmaceutical industry, pharmaceutical cleaning validation procedures are a necessary regulatory condition that must be met by pharmaceutical companies in getting safe and effectual drug formulations to patients.

The cleanliness of any pharmaceutical equipment/plant is established by using what is known as the Residual Acceptance Limits (RAL).

It is vital for a successful cleaning validation to have appropriate acceptance criteria.

GMP | Manufacturing SOP | Quality Assurance (QA) and Compliance Management | Quality Control (QC) Laboratory | Microbiology Laboratory (Sterility Testing) | GMP Auditor Training | Process, Cleaning, Method Validation | Quality and Validation Guidance | Good Working Practice | Warehouse Management | Standard Operating Procedures (SOP) for Pharmaceuticals Step by step pre-written standard operating procedures, forms, templates and manuals in the area of GMP (Good Manufacturing Practice), GLP, Production Operations, Quality Assurance Management, Quality Control & Microbiology Laboratory; Process - cleaning and methodology Validation, Regulatory auditing created for small and medium size pharmaceutical manufacturing environments.

All manuals and procedures are written by area experts in example formats in order to comply with c GMP, GLP, GDP, GAMP and international regulatory agency's requirements.

Thus the robustness of a particular cleaning procedure lies in its ability to provide quantitative data that can be compared to a different one altogether.

While this may sound obvious, in practice it is not easy to use a single criterion to assess different procedures as they are mostly validated using different techniques.

Validating cleaning procedures in biopharmaceutical manufacturing facilities