For information on cGMPs, please visit: www.fda.gov.
Part
II: Written Procedures And Record Keeping
In this second series of cGMPs Demystified, we will investigate
how companies producing dietary supplements can remain compliant
in their written procedures and record keeping. FDA rules are
filled with stipulations and guidelines for protecting the end
user against undisclosed or inaccurate product information.
The purpose of these guidelines is to establish quality standards
for the dietary supplement industry. The FDA’s final rule
contains specific information about written procedures and records
needed to operate properly.
The final rule requires manufacturers
of dietary supplements to:
Establish procedures for quality control operations
Effectively handle deviations and nonconformances (i.e. unanticipated
occurrences)
Employ qualified employees and supervisors
Handle customer complaints
Keep a written record of each product complaint related to CGMPs
Maintain records
FDA’s Final Rule on Written Procedures
for Manufacturers: Guidelines:
Employee training must be conducted in a consistent manner
Employees must exercise proper hygienic practices to prevent
contamination
Personnel must clean the plant regularly to reduce risk of contamination
and pests
Operators must check and calibrate machinery instruments and
controls
Personnel must maintain, clean and sanitize equipment and utensils
used
Manufacturers must formulate quality control operations, conduct
material reviews and make deposition decisions
Manufacturers must ensure proper labeling, packaging and handling
of products
Laboratories operations must be able to provide specifications
on products
Manufacturers must be able to handle product complaints and
help provide information for the complaint investigation
FDA’s Final Rule on Record Keeping
for Manufacturers: Guidelines:
Manufacturers must keep written records for products 1 year
past their shelf life
Companies must keep records if the products are within two years
beyond the last date of distribution
Manufacturers must keep original records on products including
photocopies, microfilm or electronic data
Companies must keep accurate electronic records which include
electronic signatures
Records must be made readily available to FDA upon request
If microfilm is used to reduce record build-up, companies must
be able to provide a suitable reader and photocopying equipment
Establish procedures for quality control operations