Equipment, Utilities and Process Validation
Process Validation is a process of establishing documentary evidence demonstrating that a procedure, process or activity carried out in production maintains the desired level of compliance at all stages. In simple words, the process validation is the collection and evaluation of data, from the process design stage till the production, as it gives scientific evidence that the process is capable of consistently providing quality products.
Medical Devices Validation services:
Validation is an important cGMP requirement & many regulatory agencies audit the validation documentation. Validation of a machine or a process is carried out to ensure that products of consistent quality are manufactured and the required level of compliance is met at every stage. Since a wide variety of procedures, processes & activities need to be validated.
Validation is divided into the following sub-sections:
- HVAC validation
- Equipment validation
- Process validation
- Facilities validation
- Cleaning validation
- Analytical method validation
- Personnel validation
- Packaging validation
- Computer system validation
During validation studies, it is very important to have the predefined protocol stating the details of the activities performed and pre-defined acceptance criteria. After the conclusion of the qualification, the statement shall be made to guide the routine processing parameters which have to be a monitoring parameter during the routine manufacturing run. The output of the validation shall be made the input for the routine control of the machines and utilities. The initial qualification of the machine/ utilities may be exhaustive for machine acceptance and parameter settings. The routine qualification may be little less exhaustive than that of the initial qualification and it has to be reported in the formal report.
Being a medical device consultant, Operon Strategist guides manufacturers & validation service providers for the validation activity & documentation. The product and the production facility are studied to document the validation master plan according to which validation activities will be performed as per the defined timeline.
We also guide manufacturers & validation service providers on the validation activity & documentation. We provide guidance for preparing process validation protocols & reports in the correct format so as to meet the regulatory requirements including DQ, IQ, OQ & PQ protocols & PQ report.