SOPs, SUS, cGMPs, Manuals
OUTLINES OF FORMATS 

(0) Introduction
 (a) Update - 05/2007
 (b) GMPs Issued Update - 06/2007
(1) Standard SUS
(2) Standard SOP - updated 08/08
(3) Small Entity SOP
(4) Professional Practice SOP
(5) Employee Manual
(6) Compliance Notebooks
(7) Specialized Documents

Index

August 2009 Update

Margaret Hamburg, M.D.
Commissioner of Food and Drugs
"Now is a good time to reassess whether you have … [a compliance] effort in place.”

Update: 05/18/07 - New GMP Standards Cleared by OMB

Sen. Hatch: Dietary Supplement cGMPs Finalized.
OMB Completes Effort to Implement Key Aspect of DSHEA

>Washington – Sen. Orrin G. Hatch (R-Utah) today announced the Office of Management and Budget (OMB) has given final clearance for good manufacturing practices (GMP) regulations for dietary supplements.
>
>“Finally!” Hatch said. “This is very good news. Senator Harkin and I have been pushing the FDA to publish these for more than a decade.”
>
>Hatch is one of the principal authors of the Dietary Supplement Health and Education Act of 1994, which gave the FDA the authority to write GMP guidelines specific to supplements. GMPs are the standards inspectors will use to assure purity, potency, and all the other requirements of clean, legal manufacturing. The GMPs are expected to be published within the next five weeks.
>
>“GMPs are crucial because they assure the public that the products they are buying live up to their labels,” Hatch said. “Since it took an unusually long time to issue these final guidelines, I want to review the final version very carefully to make certain they are good regulations. Every indication leads me to believe the Administration was very sensitive to the impact the GMPs might have on the industry, especially on small businesses.”

Update: June 22, 2007: GMPs issued.

The FDA's new Dietary Supplement Current Good Manufacturing Practices (cGMPs) are at: http://www.cfsan.fda.gov/~dms/dscgmps6.html (467 pages when downloaded to MS Word; the actual rule doesn’t start until page 426, after 359 comments…).

Here are some comments by FDA, from the commentary preceding the new rule, that tell us a lot about where the present administration of FDA wants to take us:

“…we disagree with the comments asserting dietary supplements have a track record of safety such that dietary supplement CGMP requirements are unnecessary. Section 402(g) of the act does not require us to establish a ‘bad’ track record of safety in the manufacture of dietary supplements before we may issue a dietary supplement CGMP rule. Furthermore, we disagree with the comments comparing dietary supplement safety to drug safety; there are different statutory requirements, different regulatory requirements, and different safety evaluations for dietary supplements and drugs.”

And this, from the economic impact section:

“We find that this final rule will have a significant economic impact on a substantial number of small entities.... Establishments with above average costs, and even establishments with average costs, could be hard pressed to continue to operate. Some of these may decide it is too costly and either change product lines or go out of business.... very small ... and ... small dietary supplement manufacturers ... will be at risk of going out of business.... costs per establishment are proportionally higher for very small than for large establishments....The regulatory costs of this final rule will also discourage new small businesses from entering the industry.”

The Rules become effective 08/24/07 and are being phased in over a two year period for small companies.

The Consultancy's standard formats are being updated to take into account these new rules. It is expected that by the end of summer new rules will also be posted for the Adverse Event Reporting Act of 2006, due to be implemented by 12/22/07. More about AER see: www.aer-consultants.com .

For further GMP and regulatory developments see:
http://vitaminlawyerhealthfreedom.blogspot.com

Index

(1) Standard SUS - Site Use Statement (4 pages) includes:

1. Scope of Statement
2. Terms and Conditions
      Disclosures
      Territory & Access
      No Warranties
      Non-private Communications
      Trademarks
      Testimonials
      Third Party Statements
      Accuracy
      Disclaimers
3. Privacy Statement
4. Security & Choices

More on SUS: www.siteusestatement.com

Index

(2) Standard SOP (16 pages) includes:

A.  Refund, Delivery & Returns Policies
B.  Standard Disclaimers; Site Use Statement
C.  Standard Testimonial Waiver
D.  Email Privacy Policy
E.  Document Retention Policy
F.  Quality Control Procedures - Standards, Complaints and Policy Coordination
G.  Order Processing Procedure  
H.  Bookkeeping and Account Management
I.   Order Record Keeping and Retrieval; AER Reporting
J.  Emergency Planning and Crisis Management
K. Payment Card Industry Data Security System (added 08/08)

(3) Small Entity “Record Keeping” SOP (5 pages) includes:

 I     General Provisions

 II    Record Maintenance and Production

             Tax Records
            Employment Records/Personnel Records
            Management Materials
            Press Releases/Public Filings
            Legal Files
            Marketing and Sales Documents
            Invoices, Contracts, Leases, Licenses, etc
            Development/Intellectual Property and Trade Secrets
            Final Contracts
            Electronic Mail
            Notes, Draft Copies

 III  Adverse Event Records

 IV  General Compliance Provisions

Index

(4) The Professional Practice Record Keeping SOP (4 pages) describes record keeping standards for the Advanced healthcare (CAM) practitioner who provides nutrients and natural remedies to his or her clients.

1.  Maintaining copies of all paid invoices
2.  Maintaining regular back-up copies of client database
3.  Maintaining copies product ordered for resale records

4.  Records of products ordered
A. Records showing that the products are manufactured in accordance with the marketer’s standards for the product
B. Records showing any available analysis to prevent improper manufacturing, packaging, and mislabeling
C.  Reasonably necessary records of claimed “serious adverse events.”

5.  Lawful written request for records; client objection

6. Record Types
 (a) Research and other development records
 (b) Records required by law to maintain for a certain period of time
 (c) Comply with any published records retention or destruction policies and schedules
 (d) Records relevant to litigation, or potential litigation

 (e) Practitioner establishes retention or destruction policies
 (f1) Tax Records
 (f2) Employment Records/Personnel Records
 (f3) Board and Committee Materials
 (f4) Press Releases/Public Filings
 (f5) Legal Files
 (f6) Marketing and Sales Documents
 (f7) Sales invoices, contracts, leases, licenses and other legal documentation
(f8) Development/Intellectual Property and Trade Secrets
 (f9) Trade secret information
 (f10) Contracts: final, execution copies of all contracts
 (f11) Electronic Mail

(g) Notes, drafts and documents - no longer provide relevant

(7) Compliance
(a) EU Directive on Privacy and Electronic Communications (Directive 2002/58/EC) compliance
(b) Health Insurance Portability and Accountability Act (HIPPA) compliance

7.  Practitioner Product Sales Record Keeping (in detail):
1.  The Practitioner shall maintain order invoice copies
2.  The Practitioner shall maintain back-up copies
3.  The Practitioner shall maintain copies of records
4.  Records of products
5.  Record Availability
6.  Report on FDA Form
7. Not construed by FDA as an admission

Index

(5) Employee Manual

Index

(6) Compliance Notebooks

Index

cGMPs & SoPs are Coming to the Vitamin Industry!
Proposed Current Good Manufacturing Practices
Is Your Company Ready?!?  Click below to learn more!
1. Vitamin Lawyer Report
2. Preparing for a Surprise FDA inspection!
3. Outline of my standard SoPs; Employee Manual

 Ralph Fucetola JD

Email me with questions:
ralph.fucetola@usa.net
 

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