8 Requirements for Good Manufacturing Practices

There are 8 main types of information and documentation that must be considered and addressed when implementing your good manufacturing practices.  While each plays a part that they are inter-related, you can get an overview on good manufacturing practices in general by understanding these 8 different areas.

1. Documentation

First and foremost, everything must be documented – that is written down. It’s not enough to just know or remember all the different parts, each piece needs to be written down, recorded and kept.  Off-site backups of all documentation (paper or electronic) is needed.

2. Standard Operating Procedures

Standard Operating Procedures (SOPs) are the written procedures that detail everything you do (or should be doing) to ensure your products are of the highest quality. While some directly relate to production (like making sure the space is clean or the scale calibrated), many are some steps back from the finished product (like training personnel or handling complaints). As an idea (and this is not a complete list), you should have SOPs in place for things like:

  • Documentation and filing
  • Equipment operation
  • Equipment maintenance
  • Storage (when, where, how, what)
  • Cleaning procedures
  • Pest control
  • Training staff
  • Safety procedures
  • Inventory turover
  • Numbering systems
  • Retain Samples
  • Handling product complaints
  • Handling product returns

3. Specification Sheets

Every ingredient or material that you use, including packaging materials, should have a specification sheet detailing what the exact specifications are for that item, what to do if the specifications aren’t met and the approved supplier(s) for that item.

4. Lot Numbers

Every incoming shipment of ingredients, packaging or other materials must be assigned a unique lot number which is tracked through the entire production process.

5. Master Formulas

Every formula (or “recipe”) that you use should be documented in detail, with not only the ingredients, but the processes used to make the product written in such a way that any person reasonably familiar with making products could do it without supervision.

6. Batch Records

Complete documentation of every batch made from a Master Formula, including details of exactly what was done (hopefully what is required by the Master Formula, but if not, then still exactly what was done), initialed by who did it.  Lot numbers for each ingredient or packaging material used should be included.

7. Batch Numbers

Every batch should be assigned a unique number so the batch can be tracked, and the number printed on the label of the products produced in that batch.

8. Retain Samples

A sample of each batch, in the original packaging, should be retained for at least 1 year past the expected shelf life of the product.

 

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