instant gmp compliance series - improving documentation
DESCRIPTION
The FDA enforces the Dietary Supplement Health and Education Act (DSHEA) law by inspecting dietary supplement manufacturers, packagers, labelers and holders for Current Good Manufacturing Practices (cGMPs) compliance. One of the main issues they found was the lack of proper documentation. This presentation provides an overview of the documentation that is needed for cGMP compliance.TRANSCRIPT
InstantGMP Compliance Series for Dietary Supplements
Documentation of cGMP Procedures
Electronic cGMP Manufacturing Execution System2
Background
• Dietary Supplements are orally ingested products that contain an ingredient that is intended to supplement the diet
• Not controlled by the FDA until 2007• By 2010 all manufacturers or distributors of
dietary supplements had to be in compliance with cGMP requirements
• Now 1 in 4 manufacturers inspected by FDA receive Warning Letters
Electronic cGMP Manufacturing Execution System
GMP Problems with Documentation
• Most common citation in FDA Warning Letters – inadequate documentation
• Lack of detail on written procedures• Inadequate control of specifications• Failure to perform review and disposition• Insufficient or non-existent Master Manufacturing
Records• Batch records did not follow the Master• QC did not properly disposition batch
Electronic cGMP Manufacturing Execution System
Why Documentation Is Important
• Impossible to stay in compliance without written documentation
• Used to train quality and operations staff• Assures consistency in how processes are
followed• Enforces uniformity and quality• if adulteration occurs, records will show the
source of the material so that its use can be stopped
Electronic cGMP Manufacturing Execution System
Why FDA is Hot on Documentation
• They want records to show:– What was manufactured– If controls were in place to control quality– What deviations occurred– That corrective actions were effective – If a product should be recalled– That cGMPs were followed
• In the FDA’s mind – “If it wasn’t documented, it wasn’t done”
Electronic cGMP Manufacturing Execution System
Improving Documentation
• First rule of cGMP Compliance: “Document what you do and do what you
document”
• FDA guidances on cGMP have the details• Interpretation is allowed – just write up what
you intend to do as SOPs• Then follow them
Electronic cGMP Manufacturing Execution System
Records Are Required For:
1. Personnel2. Sanitation3. Calibration of instruments and controls 4. Calibration and inspection of automated,
mechanical, or electronic equipment5. Maintaining, cleaning, and sanitizing equipment
and utensils and other contact surfaces6. Water used as a component7. Production and process controls
Electronic cGMP Manufacturing Execution System
Records Are Required For:
8. Quality control9. Components, packaging, labels and product
received for packaging and labeling10. Master manufacturing and batch production11. Laboratory operations12. Manufacturing operations13. Packaging and labeling operations14. Holding and distributing operations15. Returned dietary supplements16. Product complaints
Electronic cGMP Manufacturing Execution System
Most Common FDA Citations
• Inadequate documentation of cGMP procedures • No Master Manufacturing Records created • Batch production records had inadequate information
or didn’t follow the master• No documentation that specifications were set• No in-process control• Deviations occurred without corrective action or
documentation• Suppliers and vendors were not qualified
Electronic cGMP Manufacturing Execution System
Master Manufacturing Records Must Have:
• Complete list of components (Bill of Materials)• Weight or measure of each component • Identity and measure of each dietary ingredient• Theoretical yield at each step where control is needed• Expected yield when manufacturing is completed• Written instructions for each step of the manual
operations• Specifications at each step where control is necessary• Procedures for sampling• Where one person adds components, another person
verifies the addition• An equipment list with proper cleaning checked
Electronic cGMP Manufacturing Execution System
Batch Production Records Must Have:
• Identity of equipment and processing lines used • Date and time of the maintenance and cleaning,
or a cross-reference to logs• Identity and weight or measure of each
component• Actual yield and percent theoretical yield• Documentation that finished dietary supplement
meets specifications
Electronic cGMP Manufacturing Execution System
Batch Production Records Must Have:
• Unique batch number for each batch• Proof that quality control reviewed the BPR and
dispositioned the batch• All results which were obtained during the operation• Reference to the physical location of the label• Manufacturing steps for tablets and capsules to prevent
metal or other foreign materials from equipment getting into the batch
Electronic cGMP Manufacturing Execution System
Specifications Needed For:
• Components• In-process production• Labels and packaging• Finished batch of dietary supplement• Product that you receive from a supplier for
packaging and labeling• Packaging and labeling for the finished dietary
supplement
Electronic cGMP Manufacturing Execution System
In-Process Controls
• Must monitor the steps where control is necessary to ensure quality
• Determine whether the in-process specifications are met
• Controls include COA from qualified vendors• Dietary ingredients need identity testing• Use scientifically valid method for each specification• Quality control personnel must conduct all reviews and
make disposition decisions
Electronic cGMP Manufacturing Execution System
Deviations
• Triggered by any unanticipated occurrence could result in adulteration
• May not reprocess a batch that deviates unless approved by Quality
• Quality must conduct a material review• Then make a disposition decision• Corrective and Preventative Actions (CAPA)
needed for deviations
Electronic cGMP Manufacturing Execution System
Supplier/Vendor Qualification Programs must include:
• A program for periodic audits and re-qualifying of vendors
• Qualification of all suppliers including components, ingredients, labels, etc.
• Confirmation of vendor's test results and certificates of analysis
Electronic cGMP Manufacturing Execution System
Supplier/Vendor Qualification Programs must include:
• Reviews of specifications, procedures, and lab controls
• Assurance that all personnel affected by cGMP are trained
• Regular review of vendor’s documentation• Calibrations and recalibrations performed by
the equipment manufacturer if not done in-house
Electronic cGMP Manufacturing Execution System
How Long Must Records be Kept?
• Length of time product complaints are likely to arise
• Generally 2 years after date of distribution (not date of manufacture)
• If shelf life dating is used, 1 year past the shelf life date
Electronic cGMP Manufacturing Execution System
How Must Records be Kept?
• Records are the backbone of a quality system• FDA must have the means to examine them
during an inspection• If microfilming is used, a suitable reader must
be available• If electronic, must meet 21 CFR Part 11
requirements
Electronic cGMP Manufacturing Execution System
SOPs Made Easy
• InstantGMP maintains a complete set of manufacturing Standard Operating Procedures (SOPs) and Policies for cGMP manufacturing
• Available as individual SOPs to supplement what you already have
• Available as an entire set as a foundation for a complete quality system
www.instantgmp.com/Standard-Operating-Procedures
InstantGMP™
Find more videos on cGMP Compliance for Dietary
Supplements in the Resource Center at
www.instantgmp.com