Pharmaceutical Process Validation
Process validation for APIs is a powerful tool to demonstrate that APIs manufacturing is a process of reproducible commercial production. Based on the requirement of ICH-Q7, BOC Sciences can deliver reliable evidences to prove the commercial API production process is able to manufacture products that meet the requirements, and the process is stable in compliance with GMP requirements. BOC Sciences provides process validation related documents including project VMP, risk assessment of the production line, process validation report, and stability study results.
Our Services
To make it easier and better for researchers, BOC Sciences provides pharmaceutical process validation service in a competitive fashion. We have provided a more efficient way to increase the number of new drugs, greatly shorten the R&D cycle, and reduce the development costs.
- Process Validation Protocol (PPQ) documentation: process report, method validation report, batch production record master (MBR) and process validation plan
- PPQ batches typically include 1 or 2 pre-PPQ batches and 3 PPQ batches
- If stability test has been performed on the registered batch, our expert teams will do at least one batch of stability test on the PPQ batches, and if not, on all 3 PPQ batches
Process Validation Flow
1. The validation strategy is designed at the beginning of the validation project, and the scope and objectives of the overall validation project are defined clearly
2. A pre-approved validation protocol is established for each phase detailing the pre-requisites required prior to validation batches (e.g., device DQ, IQ, OQ, analytical method validation) and the criteria that must be met for successful validation activities
3. The results of the DoE enable critical process parameters and their normal operating ranges/proven acceptable ranges to be determined with confidence
4. Analytical objectives identified during development, DoE work and cleaning studies are also included to demonstrate that a process is under control
5. In general, we validate at least 3 consecutive batches, and when material has not been synthesized at this scale previously, we recommend to validate a 5-batche campaign for commissioning
6. The validation activity is successfully completed if the validated batches meet the pre-defined criteria
7. Once validation is complete, continued process validation and trend analysis will be performed to identify problems early and ensure the process remains under control
Figure 1. Comparison of the traditional and QbD approaches. (Raman, N.; et al. 2015)
Rigorous IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) are performed on all production equipment and facilities
During the IQ process
- Each plant equipment and critical instrumentation is listed and calibrated
- Equipment is checked for proper process and utility piping connections and materials of construction
- Electrical connections are checked to ensure proper and correct connections
- Reactor specifications, including materials of construction, piping and gasket types are verified
- Each condenser is checked and verified to ensure proper installation of process and utility piping connections
During the OQ process
- Each unit is cycled through two heating and cooling cycles
- The heating and cooling time will be recorded as the baseline
- Operation checks of the pressure and temperature recording instruments are documented
- Reaction time of the instruments will also be recorded
- Reactor agitators are cycled through their operating range to ensure proper operation and repeatability
During the PQ process
- All equipment cleaning procedures and process procedures are verified and documented
- PQ protocols and results are incorporated into our cleaning SOPs to ensure effective cleaning between batches of different production activities
- Special attention is paid to cleaning procedures during product changeovers
Why choose BOC Sciences?
Our dedicated CMC team has provided tailored solutions to our clients from engagement to launch. With many years of industry experience, we provide clients with the following:
- Comprehensive, integrated CMC services with a flexible service model that grows with your programs
- Knowledgeable industry experts who deliver scalable, actionable insights
- World-class facilities and equipment that remain at the forefront of the global pharmaceutical research, analytical and development standards
- Our comprehensive services support products at every stage of the product lifecycle, from early-stage discovery to full commercial cGMP manufacture
- A focus on risk management that is designed to ensure completion of your technical goals
BOC Sciences provides professional, rapid and high-quality services of pharmaceutical process validation at competitive prices for global customers. Personalized and customized services of pharmaceutical process validation can satisfy any innovative scientific study demands. Our clients have direct access to our staff and prompt feedback to their inquiries. If you are interested in our services, please contact us immediately!
Reference
- Raman, N.; et al. Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing. Journal of Chemistry. 2015. 2015: 1-8.
