Famar’s Quality Unit professionals, enabled by leading industry digital platforms on Regulatory Intelligence, continually survey national and international emerging legislations for prompt identification of new requirements and design of quality systems elements to implement.
Famar has developed an advanced suppliers and service providers compliance system, including auditing processes, in support of initial or alternative sourcing evaluations. The auditors have extending auditing experience and use Famar integrated methodologies for audit preparation, execution, report out, CAPA management and follow up.
ANALYTICAL METHOD TRANSFER:
The Analytical Science & Technology (AS&T) experts support on location Famar’s BU Laboratories in any case of any Physicochemical or Microbiological method is deemed in need of optimization and / or validation.
All Famar sites are equipped with stability chambers in a variety of environmental conditions to develop stability profile services of own manufactured products and as ad hoc stability services provided to customer.
PRODUCT QUALITY RISK MANAGEMENT:
With deep knowledge of Quality Risk Management principles, Famar provides integrated or ad hoc services of risks evaluation and reporting for a variety of segments such as:
- API FMD
- Elemental Impurities
- Nitrosamine Impurities
- Manufacturing Process
PROCESS VALIDATION and CONTINUED (ONGOING) PROCESS VERIFICATION - CPV:
Process Validation services during Technology of Transfer or per applied change, as well as, a fully developed program of Continued (Ongoing)Process Verification for evaluation of Critical Quality Attributes, Process Capability and advanced statistical data analysis towards an overall process robustness evaluation
PRODUCT QUALITY REVIEW - PQR:
Famar’s harmonized Group Quality System and applied eQMS provides an integrated methodology on Annual Product Quality Reviews offered as a service to the Marketing Authorization Holders under a concise and thorough evaluation of their annual product performance