Quality Assurance is responsible for ensuring the implementation and management of the quality documentation system in the organization. All master documents are stored within the Quality Assurance department and controlled semi-manually. Where electronic control is utilized, it is stored within the server that is under the management of the IT department. Appropriate security and data integrity controls are in place for these documents.
There are standard formats and procedures in place for all documents. The documents includes but is not limited to the following
- Site master file
- Quality manual
- Validation master plan
- Raw materials, packaging materials, in process, finished product specifications and method of analysis, standard test procedures
- Standard operating procedures
- Master batch records
- Stability protocol and reports
- Validation protocols and reports
All documents related to batch manufacturing and packaging are retained for a period of one year after the end of shelf-life.