cGMP for APIs and Pharmaceutical Intermediates
cGMP (current good manufacturing practices) guidelines are a series of general principles that must be observed during manufacturing of all pharmaceutical products, with the clear goal of protecting Public Health. SI Group certifies that the methods used in, and the facilities and controls used for manufacture, processing, packaging, and holding of APIs, are in conformity with current good manufacturing practices in accordance with the ICH Guideline Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
SI Group implements these cGMPs at our API manufacturing facilities in Orangeburg, SC. We proudly report neither facility has received a 483 Observation (a non-conformance report issued by the US FDA) during the last 5 years. Further, SI Group is very proud that 30 years have passed since the last 483 at our Orangeburg facility.
Basic Principles for GMP Guidelines Employed at SI Group
Manufacturing processes are clearly defined and critical control points identified and controlled. Instructions and procedures are written in clear and unambiguous language. All critical processes and equipment used to manufacture and test the material are validated to ensure consistency and compliance with specifications.
Manufacturing processes are controlled. Any changes to the process are first extensively evaluated to determine if there are any potential or likely changes to the quality of the drug. All key personnel and, as needed, customers, sign off on all changes and any changes that may impact the quality of the drug are re-validated.
Personnel are trained on Standard Operating Procedures (SOPs) to carry out and document the process.
During manufacturing, records are made to demonstrate that all the steps required by the defined procedures and instructions were followed and the expected quality and quantity of the drug was met. Deviations are investigated and documented. Records of manufacture that enable the complete batch traceability are retained in a comprehensible and accessible form.
Complaints about marketed drugs and drug substances are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective materials to prevent recurrence.
A system is available in the unlikely event of needing to recall or retrieve any batch of drug or API from sale or supply.