The following documents are listed under the category “Pharmaceutical Quality /Manufacturing Standards (CGMP)”:
- Data Integrity and Compliance with CGMP
- Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products; Revised Draft
- Field Alert Report Submission
- Repackaging of Certain Drug Products by Pharmacies and Outsourcing Facilities
- Submission of Quality Metrics Data; Revised Draft (newly added)
The related category “Pharmaceutical Quality/CMC” lists 16 additional guidances, inter alia on Microbiological Quality Considerations in Non-sterile Drug Product Manufacturing or a Technical Conformance Guide for Quality Metrics. Newly added in this category is the guidance on Elemental Impurites in Drug Product.
If you are interested to take a look at the full list of guidances, please click here.