Validating cleaning procedures in biopharmaceutical manufacturing facilities
It is important that the requirements for the finished manufacturing companies are not transferred back in the process to active pharmaceutical ingredient manufacturers without consideration for the different processes that take place at this stage.
This article examines using experimental design methods to define different procedures for intermediate bulk container cleaning.
Forms and templates are referenced in the SOPs where applicable.
Procedures and manuals are grouped into categories found in a typical GMP environment and documents are prepared to guide you through establishing a regulatory compliant facility.
The authors have evaluated this new approach, in which a highly soluble, low-dose product and a relatively insoluble high-dose product constituted experimental input variables.
Given the number and wide variety of APIs, ingredients, cleaning and processing materials used in pharmaceutical manufacturing, pharmaceutical products could potentially be contaminated with any number of substances.
Our goal is to provide a complete GMP & GLP models with a set of ready procedures and manuals which are easy to understand and readily applicable.
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.
Identical cleaning procedures should then be used for these products.4.2.1 The relevant cleaning records (signed by the operator, checked by production and reviewed by quality assurance) and source data (original results) should be kept.