GMP Services

• Third party GMP Compliance Auditing– getting ready for a new certification?  We can audit to determine what is missing from your current systems and help you build to compliance.

• Technical Writing ensuring compliance to regulations and 3rd party standards

• Specifications - raw material, packaging component, in-process, finished product.

• Master Manufacturing Records/Batch Production Records

• Standard operating procedure (SOPs, work instructions) – written procedures are the basis for training, standardization and compliance.

• Document review such as test methods, batch records, supplier qualification, OOS records.

• Validation - cleaning, IOPQ, blend studies.

 

Quality Management Systems

• Root cause investigations and CAPA resolution – We can help with investigation, root cause and verification of complex issues such as pest infestation, out of specification results in products, water or environmental monitoring. 

• Supplier/Foreign Supplier Qualification –A robust supplier qualification program will support your hazard analysis/evaluation ensuring proper preventative controls are identified along your entire supply chain. 

• Change Control Program – Implement a program that ensures changes to documents, equipment and facilities are introduced in a controlled and coordinated manner. 

• Environmental Monitoring – Create a sampling plan and controls to evaluate and mitigate presence of indicator organisms in processing areas.

• Sampling and Testing protocols – Your sampling and testing program should not only ensure compliance to regulatory requirements, but it should tie directly into your Supplier Qualification and HARPC programs ensuring robustness. 

• Key Performance Indicators – Metrics not only show where you are but will help determine how to get where you need to be.  We can help you develop meaningful metrics to support your departmental growth.