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InstantGMP Compliance Series    for Dietary SupplementsDocumentation of cGMP Procedures
Background• Dietary Supplements are orally ingested  products that contain an ingredient that is  intended to supplement t...
GMP Problems with Documentation• Most common citation in FDA Warning Letters –  inadequate documentation• Lack of detail o...
Why Documentation Is Important• Impossible to stay in compliance without written  documentation• Used to train quality and...
Why FDA is Hot on Documentation• They want records to show:    –   What was manufactured    –   If controls were in place ...
Improving Documentation• First rule of cGMP Compliance:  “Document what you do and do what you  document”• FDA guidances o...
Records Are Required For:1. Personnel2. Sanitation3. Calibration of instruments and controls4. Calibration and inspection ...
Records Are Required For:8. Quality control9. Components, packaging, labels and product    received for packaging and labe...
Most Common FDA Citations•    Inadequate documentation of cGMP procedures•    No Master Manufacturing Records created•    ...
Master Manufacturing Records Must Have:•   Complete list of components (Bill of Materials)•   Weight or measure of each co...
Batch Production Records Must Have:• Identity of equipment and processing lines used• Date and time of the maintenance and...
Batch Production Records Must Have:• Unique batch number for each batch• Proof that quality control reviewed the BPR and  ...
Specifications Needed For:• Components• In-process production• Labels and packaging• Finished batch of dietary supplement•...
In-Process Controls• Must monitor the steps where control is necessary to  ensure quality• Determine whether the in-proces...
Deviations• Triggered by any unanticipated occurrence could  result in adulteration• May not reprocess a batch that deviat...
Supplier/Vendor Qualification Programsmust include:• A program for periodic audits and re-  qualifying of vendors• Qualifi...
Supplier/Vendor Qualification Programsmust include:• Reviews of specifications, procedures, and  lab controls• Assurance t...
How Long Must Records be Kept?• Length of time product complaints are  likely to arise• Generally 2 years after date of di...
How Must Records be Kept?• Records are the backbone of a quality system• FDA must have the means to examine them  during a...
SOPs Made Easy• InstantGMP maintains a complete set of manufacturing  Standard Operating Procedures (SOPs) and Policies fo...
InstantGMP™ Find more videos on cGMP   Compliance for DietarySupplements in the Resource         Center at    www.instantg...
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Instant GMP Compliance Series - Improving Documentation

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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.

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Instant GMP Compliance Series - Improving Documentation

  1. 1. InstantGMP Compliance Series for Dietary SupplementsDocumentation of cGMP Procedures
  2. 2. 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 LettersElectronic cGMP Manufacturing Execution 2
  3. 3. 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 batchElectronic cGMP Manufacturing Execution
  4. 4. 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 stoppedElectronic cGMP Manufacturing Execution
  5. 5. 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
  6. 6. 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 themElectronic cGMP Manufacturing Execution
  7. 7. Records Are Required For:1. Personnel2. Sanitation3. Calibration of instruments and controls4. 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 controlsElectronic cGMP Manufacturing Execution
  8. 8. 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 complaintsElectronic cGMP Manufacturing Execution
  9. 9. 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 qualifiedElectronic cGMP Manufacturing Execution
  10. 10. 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 checkedElectronic cGMP Manufacturing Execution
  11. 11. 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 specificationsElectronic cGMP Manufacturing Execution
  12. 12. 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 batchElectronic cGMP Manufacturing Execution
  13. 13. 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 supplementElectronic cGMP Manufacturing Execution
  14. 14. 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 decisionsElectronic cGMP Manufacturing Execution
  15. 15. 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 deviationsElectronic cGMP Manufacturing Execution
  16. 16. Supplier/Vendor Qualification Programsmust include:• A program for periodic audits and re- qualifying of vendors• Qualification of all suppliers including components, ingredients, labels, etc.• Confirmation of vendors test results and certificates of analysisElectronic cGMP Manufacturing Execution
  17. 17. Supplier/Vendor Qualification Programsmust 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- houseElectronic cGMP Manufacturing Execution
  18. 18. 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 dateElectronic cGMP Manufacturing Execution
  19. 19. 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 requirementsElectronic cGMP Manufacturing Execution
  20. 20. 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-ProceduresElectronic cGMP Manufacturing Execution
  21. 21. InstantGMP™ Find more videos on cGMP Compliance for DietarySupplements in the Resource Center at www.instantgmp.com

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