Provide an outline of the manufacturing procedure for the finished product, including packaging.

Provide a copy of the master formula and a copy of a manufacturing record for a real batch.

For sterile products, details of sterilization processes and /or aseptic procedures used must be described.

A statement of the stages of manufacture at which sampling is carried out for in-process control tests, where other data in the documents supporting the application show such tests to be necessary for the quality control of the medicines