IKSA can provide GMP consulting support throughout the whole product lifecycle from early development through commercial launch to routine manufacture.
In line with current GMP concepts of Quality by Design, Risk Management and Pharmaceutical Quality Management Systems, IKSA can offer the appropriate expertise to meet the regulatory challenges, whatever the stage of the process.
Several IKSA Associates are Qualified Persons as defined in the EU directive 2001/83 and can provide services according to annex 16 of EU GMP, subject of course to Competent Authority approval. Services can include:
- Quality System definition and implementation
- Preparation of Quality Management documentation (policies, guidelines and procedures)
- Third party supplier auditing for API, excipients and packaging materials
- Setting up Quality Agreements and contracts with CMOs and suppliers
- Batch manufacturing and control oversight
- Batch record review
- Management and evaluation of deviations and changes
- Product release according to EU annex 16
- Preparation for, and management of, Regulatory inspections
- Responding to Regulatory observations and official communications
- Training of personnel
- Management of customer complaints
- Risk Assessments.