If your firm is ready to take a pharmaceutical entity to full GMP compliant production, we can perform an assessment of the viability of the materials control, manufacturing, testing processes, etc. that your firm is planning or has initiated. If your firm has initiated the implementation of a GMP compliant production process, the assessment will take the form of a gap analysis to identify the requirements of GMP compliance versus your firm’s existing GMP related systems. If your firm is in the planning of a GMP compliant pharmaceutical production process, we can assist during the planning and implementation phases.
Any challenges identified as a result of the assessment can be met with the assistance of Ichor Therapeutics. Our participation can include authoring of SOP’s training of employees, establishment of appropriate documentation systems; review of analytical methodology; and authoring of validation reports to support the analytical methods. As your development process continues toward NDA filing, the development of specifications (tests, limits, units, methods) for raw materials, intermediates, packaging components, active pharmaceutical ingredients, dosage forms, and stability samples, are services that we can provide. If your firm is contemplating the manufacture of dosage forms, or if you are already producing dosage, we can provide recommendations for efficient handling of samples for testing, required documentation of analytical data, and issuance of laboratory results.
Audits of pharmaceutical manufacturing firms will be performed by assessing the firm’s facilities, operational systems, and documentation versus the requirements of Title 21; Part 211 of the U.S. Food, Drug, and Cosmetic Act; entitled Good Manufacturing Practice for Finished Pharmaceuticals.
GMP status assessment
- Review of regulatory status (483’s, warning letters, EIR review)
- Physical inspection of the interior and exterior of the facility
- Annual Product Review
- Utility systems (air, input water, processed water, plumbing)
- Standard Operating Procedures (SOP)
- Employee training records
- Major manufacturing equipment IQ, OQ, PQ
- Manufacturing: process, and cleaning validation
- Packaging and labeling control
- Specifications and analytical methods to include method validation
- Sampling SOP’s to include handling, documentation, and delivery
- Laboratory testing to include investigations such as OOS
- Quality Assurance operations including deviation investigations such as CAPA’s to evaluate any preventive actions that require follow-up
- Quality Assurance system for qualification of vendors
- Complaint investigations and follow-up
- Stability system data review
The actual performance of the audit will be dependent on the type of materials being produced at the facility being audited Raw Materials; Components; A.P.I.’s (Active Pharmaceutical Ingredients); Key Intermediates; Finished Dosage Forms – sterile vs non-sterile), and/or the analytical testing being performed. The audit will be customized for your firm and an audit agenda will be provided well in advance of the audit. An audit wrap-up meeting will be held to ensure that any observations and/or recommendations for remediation will be thoroughly discussed and understood. A comprehensive audit report will be provided, if requested.
- Review of the regulatory status of the firm (483’s, warning letters, EIR review)
- Review of standard operating procedures and documentation systems
- Review of list of pharmaceuticals being manufactured at the facility, an organizational chart, and Annual Product reviews, as appropriate
- cGMP audits of contract manufacturing and/or testing services ordered by the firm
- Review of all key systems at the firm in detail to determine the level of control as evidenced by direct observation, employee interviews, and review of the required documentation