Improving Documentation of GMP Procedures - Natural Products Insider

• FDA cGMP online training programs and courses by SkillsPlus International Inc.

Follow the link below to read Richard Soltero's full article, written for dietary supplement manufacturers.

Improving Documentation of GMP Procedures - Natural Products Insider:

"Here are a few key GMP guidelines that help manufacturers avoid FDA citations and sanctions:

• Document all procedures in manufacturing operations.
• Maintain all records for plant and equipment cleaning processes.
• Mandate techniques for product sampling.
• Ensure approval by QC personnel for all procedures, tests, controls and deviations.
• Implement a control process for product labeling.
• Require QC personnel to provide results of initial or final products.
• Provide a procedure to follow if documented specifications are not met.
• Retain all written documentation for at least one year past the shelf life of the product or two years past the dissemination date of the last batch of dietary supplements."

'via Blog this'

ICH Increases Transparency - Publishes Its New Procedures Manual

ICH Looks to Increase Transparency of its Activities, Processes with New Procedures Manual:

"The International Conference on Harmonisation (ICH), a pharmaceutical regulatory harmonization body consisting of regulators from the US, EU and Japan, is publishing new documents intended to explain in full detail exactly what goes on within its regulatory black box."

For your reference:
ICH Procedures (PDF)

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SkillsPlus Intl Inc. - The Best GMP & QSR Compliance Training Around

CA HMDR Facilities Must Have Policies and Procedures

• California HMDR Exemptee Training Certification Course (accepted by the California Department of Public Health - Food and Drug Branch) - Buy Now!

Updated July 6, 2021

Pricing – Standard Operating Procedures Course

• $100 per student when co-purchased with our California Exemptee training course.
• Select our Writing Standard Operating Procedures (SOP) Couse as an optional “add-on” course when you purchase our California HMDR Exemptee license training certification course. In other words, buy this course, then add the optional SOP course during registration.

---  the original post follows below  ---

Policies & Procedures Required For CA HMDR Facilities

The CA Home Medical Device Retailer (HMDR) licensing program is governed by law sections found in the California Sherman Food, Drug and Cosmetic Law. The Sherman Law was amended in the 1999-2000 legislative session to establish the HMDR licensing program. The applicable sections can be found in an abstract of the Sherman Law.

Section 111656.3 starts out with:

"Each home medical device retail facility shall have written policies and procedures related to home medical device handling and, if authorized by the department pursuant to Section 111656.4, the dispensing of prescription devices. Those written policies and procedures shall be adequate to assure compliance with this article and shall include, but not be limited to . . . "

Notice the phrase, " . . . shall have written policies and procedures . . . "

Not quite sure how to begin, and start writing them?

Then you might be interested in:
Buy Now: Writing Procedures: Drug and Device Wholesalers and HMDR 
 - an online training course from SkillsPlus International Inc.

Learn to write procedures quickly and thoroughly. Allan shares his experiences and techniques for writing procedures. This class is based on 30 years of experience writing procedures and teaching others to write them. This class is only for drug and device wholesalers, DME's and home medical device retailers. Pharmacists and pharmacy technicians responsible for procedures in their firm may also benefit. 

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Training program for California Home Medical Device Retailer (HMDR) Exemptee license applicants

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