Hardware Validation and Maintenance Services Regulatory Guidance
The need to qualify and validate equipment and test methods is described in various compendia and regulatory guidance documents. For example;
- EU GMP directives 91/356/EEC and 91/412/EEC
"Premises and equipment intended to be used for manufacturing operations which are critical for the quality of the products shall be subjected to appropriate qualification.”
- USP, 1058
“This chapter provides a scientific approach to AIQ and considers AIQ as one of the major components required for generating reliable and consistent data.”
“A periodic preventive maintenance may also be recommended for many instruments. The relevant PQ test(s) should be repeated after the needed maintenance or repair to ensure that the instrument remains qualified."
- 21 CFR 211.84 (d) (2). Testing and approval or rejection of components, drug product containers, and closures.
“...the manufacturer establishes the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.”
- 21 CFR part 211.194 (2) Laboratory records
“...the suitability of all testing methods used shall be verified under actual conditions of use”. Proving the suitability of testing method means demonstrating and documenting that, under actual conditions of use, it provides the expected results.
Millipore Services Portfolio for Microbiology Equipment
Biopharmaceutical manufacturers worldwide must constantly keep pace with an increasingly regulated environment. The validation work, documentation and administration required to do so is time-consuming, and very often means a shift in focus from the manufacturing and the quality control of the product itself, to perform the required regulatory tests. In many cases, the supplier of a testing method or a contract laboratory has specialized knowledge that could ease the burden of this workload for manufacturers and free their resources for other tasks.
Test method validation also consumes resources in the quality control unit. Millipore can support the quick implementation of a critical test that is fully compliant with current regulations. We provide a high level of expertise on both applications and equipment used within the Quality Control Laboratory. We offer a complete range of Services for our Microbiology hardware:
