Material Specifications required in Master Manufacturing Records

Recently, a question was posed in a LinkedIn group regarding revising Master Manufacturing Records and whether specifications need to be included in the record. When revising MMRs or MPRs, you should first consult your SOPs for document control, MMRs and specifications. Specifications should be separate documents including the tests, methods, limits and frequency of testing 21 CFR Part 111.210 subpart H states you must include the following written instructions in the MMR:

  1. Specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
  2. Procedures for sampling and a cross-reference to procedures for tests or examinations.
  3. Specific actions necessary to perform and verify points, steps, or stages in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record.

Subpart E Sec. 111.70 – What specifications must you establish for the in-process production?

  1. You must establish in-process specs for any point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement.
  2. You must provide adequate documentation of your basis for why meeting the in-process specifications, in combination with meeting component specifications, will help ensure that the specs are met for the identity, purity, strength, and composition of the dietary supplements and for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement.

Therefore, in-process and final product specifications should be stated in the MMR, while other specs such as those for raw materials not tested at the batch level should be kept separately. In addition to the specifications themselves, documentation of validation that the tests performed are sufficient to assess the identity, purity, strength and composition of the dietary supplement. Maintaining redundant specs can cause extra documentation and need for cross-references, so it is important that this is noted in your MMR creation protocol as well as Change control and specification Standard Operating Procedures. Traceability and transparency is the key.

Learn More
For detailed information visit: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=111&showFR=1&subpartNode=21:2.0.1.1.11.8

Download a PDF:  http://www.gpo.gov/fdsys/granule/CFR-2011-title21-vol2/CFR-2011-title21-vol2-sec111-210

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