ISO 9000 series, 13485:2003, 15378:2006 - Small Compounding Pharmacy

I

irv6744

#1
hi

This is all new to us.

We are a small (1 pharmacist and 1 employee) compounding pharmacy in california and would like to sell some of our products in bulk to the doctors for office use.
Many states consider that to be manufacturing so we checked the California application for a drug manufacturer.
We have to show:

A copy of documentation demonstrating compliance with audits conducted pursuant to International Organization for Standardization (ISO) ISO standards (ISO 9000 series, ISO 13485:2003, ISO 15378:2006

Hopefully i can get some guidance here and get answers to my questions.
I read another thread that said 15378 might be the only thing we have to do but this area is so confusing to me..
Is this a project we should even begin to undertake considering our very small size.
Are there people in California that can act as our shepherds to help us wade through this process.
Is there a place i can get some nice simple explanations as to what we have to do.

Thanks a lot for any help i can get.

irv
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
General Note:

ISO 15378:2011 - Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
 

Ajit Basrur

Staff member
Admin
#3
Welcome to the Cove, irv :bigwave:

The standards you have mentioned are applicable for Medical Devices ... from small compounding Pharmacy that you mentioned, it refers to Pharmaceuticals and not Medical Devices.

Can you give more info ?
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna ISO wants Feedback: ISO Survey on USE of ISO 9000:2000 Series of Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
D ISO 9000 series language requirements QS-9000 - American Automotive Manufacturers Standard 2
Q Choosing between ISO 9001 (2015) & TL 9000 certifications ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
qualprod In ISO 9000, Standard vocabulary - Competitors , interested parties? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Happy 30th Birthday, ISO 9000! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO 9000 Standard "standard" definition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M What is the difference between ISO 9000 and ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Where to purchase ISO 9001:2008 and ISO 9000:2005? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO 9000 World Conference and Draft changes to new revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Moving steps from ISO 9001 to TL 9000 TL 9000 Telecommunications Standard and QuEST 4
O ISO 9000 section 7.2.1(c) Compliance help needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Exploding the Myths Surrounding ISO 9000: A Practical Implementation Guide Book, Video, Blog and Web Site Reviews and Recommendations 28
Q How to correlate the 8 Quality Management Principles to ISO 9000 standards ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Is ISO 9001 a prerequisite to TL 9000 certification? TL 9000 Telecommunications Standard and QuEST 5
optomist1 ISO 9001 vs TL 9000 - Looking for a comparison matrix Other ISO and International Standards and European Regulations 3
Q ISO 9000 Conference Istanbul-Turkey - Looking for Speakers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S New to ISO/TS16949 - Our QS-9000 certification has expired IATF 16949 - Automotive Quality Systems Standard 3
Project Man What is the most current ISO 9000 standard? I heard there is an ISO 9100 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M "ISO 9000 Quality Systems Handbook" by David Hoyle Book, Video, Blog and Web Site Reviews and Recommendations 24
N How does a company determine what ISO standard (9000 or 9001) to register to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Full Job Description and Responsibilities in ISO 9000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Documents required to display/keep during ISO 9000 Audit in EPCC firm ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
apestate Question on wording in DOD RFQ regarding ISO 9000 Various Other Specifications, Standards, and related Requirements 7
R New 13485 Registration questions - Currently registered to ISO 9001 and TL 9000 ISO 13485:2016 - Medical Device Quality Management Systems 2
L Copies of ISO 9000:2005 and ISO 9004:2009 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna The ISO 9000 ecosystem - a clear(?) vision for the future of the ISO 9000 family ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T ISO 9000 / Lean Six Sigma Survey - University Study - Seeking Respondents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Sidney Vianna I Married a Monster from ISO 9000 Coffee Break and Water Cooler Discussions 2
Scott Catron Dilbert and ISO 9000 Funny Stuff - Jokes and Humour 0
V Opinions of those who have used/read David Hoyle's ISO 9000 Handbook Book, Video, Blog and Web Site Reviews and Recommendations 2
M ISO 9000/Lean Six Sigma Conference - Orlando March 2010 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Changes I have to make in the QMS - ISO 9000:2000 to ISO 9000:2008 Software Quality Assurance 4
T STR-ISO 9000 - "Super ISO' audit that the Navy performs every 3 years Various Other Specifications, Standards, and related Requirements 11
L Definition Quality Management System (QMS) as per ISO 9000:2005 - Definition of Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
J How to understand NOTE 2 in the ISO 9000 definition of defect? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Is a self-review of documents allowed in ISO 9000? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Bilijaf ISO 9000 video clip- download ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Sidney Vianna New edition of ISO brochure on getting the best out of ISO 9000 family ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Changes on the horizon for ISO 9000:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO launches video clip: "The ISO 9000 family ? Global management standards" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Starting the journey (ISO 9000 awareness) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Using ISO 9000 family to help us to improve the efficiency of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9000:2005-Copy requested of Drafts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
G Quick Reference for the 8 Quality Management Principles in ISO 9000 IATF 16949 - Automotive Quality Systems Standard 2
Sidney Vianna ISO advises managers how to get the best out of the ISO 9000 family ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T ISO 9004:9000 Case study needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Example of an ISO 9000-2000 QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
sathis Is Master Sample a Document? - ISO 9000:2000, Clause 3.7.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
J Approval of Grandfathered Documents - ISO 9000:2000 Clauses 4.2.3 a&b Document Control Systems, Procedures, Forms and Templates 9
J ISO 9000 vs. AS9100 in a Local Fabrication and Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4

Similar threads

Top Bottom