In this whitepaper, the Manufacturing Technical Committee of the Product Quality Research Institute provides information on the common, best practices in use today in the development of high-quality chemistry, manufacturing and controls documentation.
BY and WEK prepared and qualified all reagents in the IHC tests and maintained manufacturing and QA/QC documentation for the tests to be sent to the independent CLIA laboratory that carried out the staining.
Delivery of technical documentation of manufacturing facilities is still mandatory for machinery and plant engineers as part of the compliance with legal regulations.
Measurements at a fixed location in a given reactor are useful in understanding changes in mixing that occur during the course of a given process, and are useful in manufacturing situations where validated documentation of lot-to-lot consistency of mixing is required (e.g. pharmaceutical manufacturing).
However, increased burden has been placed on individual laboratories for assuring good manufacturing practice (GMP) through heavy documentation of each step en route to the clinical examination.
Documentation is critical to a well-controlled manufacturing environment.
Moreover, at times this study followed the current Good Manufacturing Practices (cGMP) regulations particularly in terms of equipment validation and documentation.
That not only means actually manufacturing the product, but also managing all the ancillary stuff like packaging, documentation, shipping and fulfillment.
It also provides the documentation that allows the equipment to be validated by the manufacturer to meet FDA requirements for manufacturing quality.
Design documentation is one of the four critical elements of profitable product manufacturing.
When developing a new drug product, it is prudent to plan for dissolution documentation during all phases of drug development so that if a change is needed in formulation, manufacturing process, equipment, or manufacturing site, dissolution profiles and f2 data can be used in lieu of the need to conduct PK/clinical trials.
