CMC SERVICES
QUALITY ASSURANCE AUDITS
DS InPharmatics is a full-service CMC consulting firm with experience and expertise in each of the sub-disciplines of Chemistry, Manufacturing and Controls (CMC).
Quality Assurance Audits
DSI consultants and auditors are highly qualified with a thorough understanding of current GXP (GMP, GLP, GCP) quality systems. Our Quality associates meet the highest standards of professional performance and are members of professional organizations such as American Society for Quality (ASQ), Parenteral Drug Association (PDA), American Association of Pharmaceutical Scientists (AAPS) and International Society of Pharmaceutical Engineers (ISPE).
DSI consultants work with our clients to clearly define key requirements. cGMP audits include a comprehensive review of document control; personnel qualifications and training; equipment/ personnel and process flows; facility and equipment design/construction and maintenance; environmental control and monitoring; laboratories and procedures; equipment cleaning; materials handling; control and warehousing; and facilities and process validation.
We carefully review site master files, SOP’s, batch records, documentation systems, analytical data and COA’s, OOS reporting and trending, records of deviations/incidents and trending, regulatory audits and findings, and change control systems. Clients receive a written assessment of audit findings, and any deficiencies are highlighted.
Quality Operations
Our CMC teams can also act as your internal Quality department or work with your existing personnel to implement a practical Quality Assurance program that is compliant with regulatory requirements and specifically tailored to suit your organizational structure.
For small, emerging pharmaceutical companies, DSI can provide a customized set of Standard Operating Procedures (SOPs) to establish a basic and functional Quality System that can be used for Phase 1-3 drug development programs.
FDA 483 Response Support – FDA observations are recorded on a Form 483 after an inspection. The 483 may mean that you have deviated from regulations and guidance or the investigator does not like the way something is being done. We can assist you in responding to the observations and ensuring your operations are minimally impacted.
CAPA Development/Support- Corrective and preventive actions (CAPA) look at past and future nonconformance events. Too often companies implement more procedures as the remedy thereby increasing the likelihood of more events and overhead expenses. We can assist you in performing root cause analysis and recommend viable solutions for operational efficiency.