C&A provides Qualification and Validation services in full compliance with cGMP standards, with integration of modern CQV strategies and using/implementing risk-based approaches to process validation and writing all client’s SOPs. The Qualification and Validation of process equipment require strong basis, such as Master Planning, Acceptance Criteria Development and Protocol Execution in addition to Good Engineering Practices (GEP) and through Process Validation & Cleaning Validation.  The risk-based validation approach is a “lifecycle” activity synchronized with drug production activities not a one-time event.

C&A has worked with clients to create comprehensive Validation Master Plans (VMP) for sites.  We provided the clients the technical expertise, helped develop testing procedures and determine acceptance Criteria for new drug products.  We use electronic document management systems to manage validation documents and to facilitate efficient review, approval, and execution of protocols, coordinate approval of deviations and investigations and CAPA systems.

Validation Master Planning & Management
C&A  manages to leverage commissioning documents in an efficient method and satisfy qualification protocol requirements- assisting in equipment FAT & SAT and gaining speed & understanding from the start of the construction phases of a project.

We support the risk-based approach centering on the implementation of the ASTM E-2500 Standard in comparison to the traditional Installation, Operational, and Performance Qualification (IOPQ) “V-model” to validation.  Our philosophy is to support the engineering phase to provide value-added CQ &V services.

Qualification and Validation Expertise
During the Qualification and Validation Phase, we verify and record operations and performance of systems and equipment under the commissioning plan and leverage records from commissioning into protocols.  We review test protocols for systems to be validated in accordance with impact assessments.  Summary of executing test protocols -IOQ and PQ, PV and CV for ensuring validated systems, equipment and processes can be maintained under schedules of requalification and or continuous monitoring and trending and ensuring an effective corrective and preventative actions (CAPA) system.

Test Procedures and Acceptance Criteria Development
C&A has supported clients’ efforts to adhere to the guidelines the FDA has provided for the setting and justifying of acceptance criteria as well as the selection of test procedures for new drug substances.  From justifying “periodic or skip testing” to selecting regional “pharmacopeias tests and acceptance criteria” to using “evolving technologies” for added Quality Assurance, we provide leadership during this critical step to manufacture a new product compliant with cGMP requirements.