QPC’s Validation Services use the “ABC” (Accuracy, Brevity, and Clarity) approach to medical and pharmacutical related manufacturing process validation.
Compliance is naturally job # 1, however ensuring youre processes are efficient in terms of resources, time and cost are also important. Our Validation Services are scalable, ranging from our “VIY” (Validate It Yourself) program to our full service validation program. No matter which approach you choose, “validation prerequisites” must be accomplished before validation activities begin.
Specifically, the following must be in order before starting validation activities:
- The Device Master Record (DMR) must be current and specifications must be complete and accurate
- Utility systems must be identified and selected
- Inspection, Measurement, and Test Equipment (IMTE) must be calibrated
- Personnel who will be directly involved in validation activities must be qualified and adequately trained on the planned validation activities
The keys to good validation practices are:
- Validation prerequisites must be met
- Validation planning must be comprehensive
Validation protocols must contain the following:
- Comprehensive instruction on how to perform the validation
- Crystal clear acceptance criteria
- Comprehensive instruction on how to handle deviations and test failures
- Validation reports must be accurate, brief, and clearly state the validation outcome
- All supporting objective evidence and data must be adequately cataloged and controlled
This is not as easy as it sounds. For most small companies, validation is not a routine activity. Let QPC Services help you get it right the first time.
TTo find out how we can help your business, contact us today for a free, no-obligation consultation.