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Showing posts with label OPS 4 SOPs. Show all posts
Showing posts with label OPS 4 SOPs. Show all posts
Wednesday, May 27, 2020
May 2020 Newsletter: Reopening the Natural Economy
Friday, March 13, 2020
March 2020 Pandemic Newsletter
PANDEMIC!
EMERGENCY PLANNING SOP
Everyone is worried about COVID-19 and every company is impacted by it.
I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.
My regular retainer clients are receiving a copy of the revised SOP and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.
Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency!
If you want a copy of SOP #13, the cost is just $99 -- email me and I'll send you a PayPal money request.
But during this emergency, I want everyone to have the information they need to protect their company. So here is the new section of SOP #13, so you can get ready for remote working if you find your company under lock-down.
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[2] Working Remotely - It may be necessary for some or all staff to work remotely during an emergency. In advance of such contingency the Emergency Manager should:
I have updated my Standard Operating Procedures (SOP) format to add Working Remotely to SOP #13, Emergency Planning.
My regular retainer clients are receiving a copy of the revised SOP and those retainer companies that are part of my OPS for SOPs -- my on-line facility for Systems Processing Integration -- www.SystemsProcessingIntegration.com -- are having their SOPs automatically updated by me.
Remember the OPS (Operating Procedures System) is a password-protected online page which houses copies of your SOPs and other primary regulatory documentation... just what you need during an emergency!
If you want a copy of SOP #13, the cost is just $99 -- email me and I'll send you a PayPal money request.
But during this emergency, I want everyone to have the information they need to protect their company. So here is the new section of SOP #13, so you can get ready for remote working if you find your company under lock-down.
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[2] Working Remotely - It may be necessary for some or all staff to work remotely during an emergency. In advance of such contingency the Emergency Manager should:
- Establish an Online Communication System, such as (1) Skype or Zoom, instructing all staff to have access to the system via cell phone and home computer; (2) a Conference Call Bridge number should also be established and (3) a Push Notice System can be established to text group messages to staff member cell phones.
- Designate staff members who are essential to operations and who should, if possible, work from the facility.
- Designate staff members who can continue their work remotely.
- Designate times and circumstances where staff members should call the Conference Call Bridge for instructions or text instructions to staff members’ cell phones.
I also included one additional duty to the general duties of your Emergency Manager (Section 1 of the SOP): "Maintain a list of staff members and their cell phones for text messaging and conference calling; this list should be maintained on a password-protected Internet Page which is part of the Company online OPS."
Please let me know how I can help your company during this emergency.
Dr. Laibow and I are maintaining a COVID information aggregation site here: www.TruthAboutCoronavirus.com
We are planning a COVID Emergency Health Summit; more information here: http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/
Please let me know how I can help your company during this emergency.
Dr. Laibow and I are maintaining a COVID information aggregation site here: www.TruthAboutCoronavirus.com
We are planning a COVID Emergency Health Summit; more information here: http://www.inhere.org/2020/03/07/covid-19-emergency-health-summit/
Wednesday, January 29, 2020
Announcing: SPI Associates
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Monday, January 15, 2018
FDA 2017 WARNING LETTERS
FDA IS CONCERNED ABOUT QUALITY CONTROL
AND SO SHOULD YOU BE...
Each year it is possible to see the trends in FDA inspections and concerns. This practice note looks at some of the typical letters that show us what those concerns have been in recent months.
There are four main areas that I've noted:
[1] Citing medical journal "disease claim" articles to support claims is not allowed.
"When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use."
[2] Failure to establish a system of process and production controls must be addressed.
"...a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record..."
[3] Making medical claims for DSHEA products is never allowed.
"...regular consumption ... may help stave off disease…." / "...reduced inflammation..."
[4] Quality Control / QC Manager issues are primary.
"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement..."
Here are some more detailed excerpts from the Warning Letters reviewed that show you in detail how FDA approaches these issues, followed by my recommendations.
[A] Vita Purity
(i) Disease Claim Citations
"Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease...
(ii) Production and Process Controls
...You failed to establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). Specifically, you had no written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103, and no written procedures for approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
You receive finished, packaged and labeled dietary supplements from a manufacturer that manufactures the dietary supplements on your behalf (your contract manufacturer). You hold and distribute the dietary supplements. You state that you specify the active ingredients and their proportions for each of your products. You design and approve the product labels and have them printed and shipped to your contract manufacturer. You sometimes procure dietary ingredients and supply them to your contract manufacturer. You state that you assume your contract manufacturer is responsible for preparing a master manufacturing record, exercising quality control functions, and verifying that the finished products meet specifications. You state that you assume your contract manufacturer is complying with 21 CFR Part 111 because you are unaware of any problems at the plant. You state that you do not have a written agreement with your contract manufacturer, and have not performed any audit or engaged in any other activity to determine the acceptability of the manufacturer to manufacture your dietary supplement products, or to ensure the quality of the dietary supplements received and that the products are packaged and labeled as specified in the master manufacturing record.
As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements. [1] In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2))."
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm559804.htm
[B] Maine Natural Health
(i) Disallowed claims
“Vitamin D [an ingredient in the product] may improve heart health…. heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.”
“Benefits of fish oil [an ingredient in the product] include: reduced inflammation”
“[T]he omega-3 fatty acids in fish oil [an ingredient in the product]…have shown beneficial results for a variety of health problems….like high blood pressure and arthritis. This means regular consumption of fish oil may help stave off disease….”
(ii) Master Manufacturing Record Required
"You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection we noted that you are not preparing master manufacturing records that are unique to the batch sizes being manufactured for each of your dietary supplements. For example, our review of your records indicated that on May 5, 2016, you manufactured one batch of Vanilla Recovery Whey Protein using (b)(4) with a final batch size of (b)(4) and on July 5, 2016, you manufactured another batch of the same product using (b)(4) with a final batch size of (b)(4) following the same master manufacturing record for each batch.
Additionally, in preparing your master manufacturing records for all dietary supplements you manufacture, you must ensure that they meet the requirements of 21 CFR 111.210. For example, the current master manufacturing record for [redacted] Whey Protein does not include the strength, concentration, weight, or measure of each dietary ingredient for each batch size, as required by 21 CFR 111.210(a)."
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590003.htm
[C] Brain Alert
(i) Ultimate Responsibility for Your Own Labels
"Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements [see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)]. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations. "
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589575.htm
[D] Dynamic Technical Formulations
(i) Quality Control Personnel
"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [see 21 CFR 111.105(a)]. Additionally, the personnel you identified to perform quality control operations do not have the education, training, or experience to perform quality control functions, as required by 21 CFR 111.12(c). Specifically, you identified yourself to our investigator as the quality manager, but admitted that you were not familiar with the Dietary Supplement GMPs and had not received any training to perform the duties associated with quality control.
To fulfill the requirements for quality control operations, your firm must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65."
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589584.htm
BOTTOM LINE -- RECOMMENDATIONS FOR ACTION
We can see from these warnings that the industry is being held to ever higher standards of conduct, as FDA seeks to impose strict Quality Controls. The position of Quality Control Manager is very important. FDA prefers that the QCM is not the Chief Operating Officer, the COO, but reports to, and has immediate access to, the COO and CEO. Each company needs to appoint and train a QCM (and be able to substantiate that training).
My quarter-hour Quality Control webinar (with eBook) covers the duties and qualifications of your QCM. If you want to see my 26 slide presentation, please let me know. I'd be happy to send you the link to the eBook, which has just been posted with the Webinar. If you have access to my Webinar System you can find it there. If not, why not? http://www.vitaminconsultancy.com/webinars.php
These newsletters are archived here: http://vitaminlawyerarchives.blogspot.com/
THE CLOCK IS TICKING...
CALIFORNIA PROP 65 WILL IMPACT YOUR BUSINESS THIS YEAR!
Saturday, July 1, 2017
OPS for SOPs
INDEX:
OPS 4 SOPs
Branding Basics
This Article Also Posted Here:
http://vitaminconsultancycertification.weebly.com/ops-4-sops.html
Standard Operating Procedures and OPS
This newsletter describes the Standard Operating Procedures (SOP) Operating Procedures System (OPS) which the Vitamin Consultancy maintains for our monthly retainer clients.
A New Vitamin Consultancy Service
Operating Procedures System - OPS
SOP Maintenance
Branding Profile
Operating Procedures System - OPS
SOP Maintenance
Branding Profile
Dietary Supplement purveyors face an ever-changing regulatory climate as various federal agencies, led by FDA, seek to control the market. After practicing law for 36 years, gaining a reputation as The Vitamin Lawyer, I focused my efforts on The Vitamin Consultancy which brings top-level regulatory services to medium and small vitamin companies.
Those services include not only FDA-vetted, GMP compliant Standard Operating Procedure (SOP) formats, but also a webinar training program that teaches how to use SOPs to meet regulatory requirements -- and more, with specialized webinars on topics such as The Forbidden Words, to keep your company ahead of the curve. I provide GMP audits and copy/label/claims reviews.
In addition to keeping an eye on FDA regulatory developments through the Agency web site and various industry newsletters, I also have people coming to me for my advice who have been recently inspected by FDA and received "Comment" letters. Often these letters are an "early warning" of FDA regulatory focus, giving me the opportunity to prepare you for the changing regulatory environment.
As a result of some language used in a recent FDA letter to a company selling homeopathic patches, I saw that FDA was recommending certain language, in effect, for the Quality Control (QC) parts of the SOPs, more clearly specifying the role of the Quality Control Manager (yes, in a small company the CEO/COO may also be the QCM), so I created certain amendments to the SOPs to cover this new FDA focus and clarify the role of the QCM.This is one way for Vitamin Consultancy clients to stay a head of the curve. [BTW, I am working on a new webinar about the role of the QCM.]
While there is a Change Procedure in the SOPs, how will such changes be communicated and implemented?
I've been thinking, therefore, about how to more effectively automate the process. I suggest it may be time to "go digital" with the Operating Procedures System -- OPS.
Using the paper file hard-copy as a back up, the company could have a private [password protected] online OPS copy as the official copy.
Even, or especially, in an emergency managers would have access to necessary procedures from their smart phones that would give them always up-to-date copies of the procedures. Properly indexed with hyperlinks, the necessary information would always be available, and, perhaps more importantly, FDA would see that there is a system in place to ensure that the most up-to-date procedures are being implemented.
In addition to the SOP format that I've prepared there are probably other formal or informal operating procedures that should be recorded, not necessarily for FDA compliance, but for brand and operations consistency.
The Operating Procedures System could become a repository for the company culture, for such essential factors as the Company Branding Profile (see article below).
Properly developed and maintained, the OPS can be a valuable company asset.
The Vitamin Consultancy's SOP Maintenance System provides your company with a powerful tool for the continued regulatory compliance of your operations. Here is how it works:
1. The Company and the Consultancy enter into a privacy contract for the maintenance of the OPS. The maintenance fee is included in the monthly retainer.
2. The SOP document, based on the Consultancy format, is finalized with the Company and posted on the protected site. Only the OPS Administrator, provided by the Consultancy, has authority to change the document (and with company COO approval). Additional operations documents that may be useful can also be posted, under COO direction.
3. The Company specifies which managers are to have access. That access is granted to specific email addresses and can be password protected. At any time access can be terminated.
4. The Consultancy will keep the SOPs up-to-date and will notify the managers, through the master list, of changes.
5. These procedures will themselves be set down in a new SOP specifying the OPS Online Official SOPs.
Here is an outline of the Operating Procedures System:
[1] The SOP document details the operating procedures of the Company, in conformity with FDA and FTC regulations of dietary supplement and similar businesses. See SOP Index below.
[2] The OPS is the private online repository for the updated official copy of the SOP document, available to the managers of the Company.
[3] The OPS consists of a Google Documents file folder and subfolders with the following items:
- The OPS Use Memorandum
- The SOP indexed manual consisting, currently, of 24 specific SOPs
- The SOP Appendix with standard forms
- The Company Branding Profile
- The CCDS (Company Core Data Sheet) for each current product.
[4] The SOP Manual consists of the following procedures:
1. Introduction / Index
2. Refund, Delivery & Returns Policies
3. Standard Disclaimers; Site Use Statement
4. Standard Waivers: Model – Testimonial – Clinical Study
5. Email Privacy Policy
6. Document Retention Policy
7. Quality Control / Claims Control / Complaints
8. Contract Manufacturer Agreement GMP Enforcement Terms
9. Password and Internet/Program Access Controls
10. Order Processing Procedure
11. Bookkeeping and Account Management
12. Order Record Keeping and Retrieval; AER Reporting
13. Emergency Planning and Crisis Management
14. Payment Card Industry Data Security System
15. Private Labeling / Labels
16. Receiving, Handling, Shipping & Storage of Inventory and Returns
17. Recalls
18. Complaint Form
19. Change Controls / New SOPs
20. CAPA
21. CCDS (Company Core Data Sheets)
22. New Employee Qualification and Training
23. Official Inspections: Procedures
24. New Product Development; Product Retirement & Archiving
[5] The SOP Appendix includes these forms:
Waivers
Complaint Form
CCDS Form
Contract Terms
Social Media Schedule / Program Access
[6] These are records are kept in the ordinary course of business and may be offered as evidence in court. The Branding Profile is an expression of the company’s Intellectual Property and claims to trademarks, trade dress and branding indicia.
[7] The following Positions in the Company are listed in the SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager.
The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO
[8] All managers shall maintain online access to the current SOPs at all times; for example, on their smart phones.
[9] The private link to the OPS Google Docs folder which includes the SOPs can be provided to anyone in the company, or any consultant, who needs access to the OPS
Depending on company size, the Vitamin Consultancy can maintain your OPS and their contents for as little as an hour a month retainer. For that you receive our guidance on developing your SOPs, including FDA-compliant forms, your basic Company Branding Profile (more about that below) and our private client alerts regarding breaking FDA and FTC news impacting natural products. Of course, we set up and maintain your OPS online.
Interested? Call Ralph: 973.300.4594. We invoice monthly through PayPal.
1. Introduction / Index
2. Refund, Delivery & Returns Policies
3. Standard Disclaimers; Site Use Statement
4. Standard Waivers: Model – Testimonial – Clinical Study
5. Email Privacy Policy
6. Document Retention Policy
7. Quality Control / Claims Control / Complaints
8. Contract Manufacturer Agreement GMP Enforcement Terms
9. Password and Internet/Program Access Controls
10. Order Processing Procedure
11. Bookkeeping and Account Management
12. Order Record Keeping and Retrieval; AER Reporting
13. Emergency Planning and Crisis Management
14. Payment Card Industry Data Security System
15. Private Labeling / Labels
16. Receiving, Handling, Shipping & Storage of Inventory and Returns
17. Recalls
18. Complaint Form
19. Change Controls / New SOPs
20. CAPA
21. CCDS (Company Core Data Sheets)
22. New Employee Qualification and Training
23. Official Inspections: Procedures
24. New Product Development; Product Retirement & Archiving
[5] The SOP Appendix includes these forms:
Waivers
Complaint Form
CCDS Form
Contract Terms
Social Media Schedule / Program Access
[6] These are records are kept in the ordinary course of business and may be offered as evidence in court. The Branding Profile is an expression of the company’s Intellectual Property and claims to trademarks, trade dress and branding indicia.
[7] The following Positions in the Company are listed in the SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager.
The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO
[8] All managers shall maintain online access to the current SOPs at all times; for example, on their smart phones.
[9] The private link to the OPS Google Docs folder which includes the SOPs can be provided to anyone in the company, or any consultant, who needs access to the OPS
Depending on company size, the Vitamin Consultancy can maintain your OPS and their contents for as little as an hour a month retainer. For that you receive our guidance on developing your SOPs, including FDA-compliant forms, your basic Company Branding Profile (more about that below) and our private client alerts regarding breaking FDA and FTC news impacting natural products. Of course, we set up and maintain your OPS online.
Interested? Call Ralph: 973.300.4594. We invoice monthly through PayPal.
COMPANY BRANDING PROFILE
What is a company Branding Profile? It is an organized document that is part of the Intellectual Property of the company. It adds value to the company by better defining the company brand.
The Profile covers such issues as patents and trademarks, slogans; trade names and logos; precisely what colors represent the company; what typeface fonts; what types of images, the "look and feel" of the labeling and sales copy (trade dress; branding indicia). Standard advertising language may be cataloged. The Company Mission should be included.
One Branding Agency lists:
"The brand codification process typically involves defining and aligning elements like:
- Target audience / segments
- Target beliefs & perceptions
- Target options / competitors
- Category
- Value proposition
- Position
- Speaking points
- Personality
- Selling points
- Tone & manner
- Visual profile
- Backstory
- Brand persona
- Brand architecture
- Vision, mission, goals"
The Branding Profile is intended to offer guidance to the copywriters and customer service people in the company, as well as the planners and managers.
That is why this essential part of the company culture rightfully belongs in the OPS, as one of the chief expressions of the company's mission.
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