SBS - The Best Value in QMS software

"GMP Area" - FDA definition

A

AREZA

#1
Can a firm make a ‘GMP area’ in one big room/hall of its buildings and register itself with FDA as a drug establishment. Only intending to make antimicrobial hand sanitizers and hand bacterial hand soaps inside that area. we can only ensure compliance in that GMP area? We will produce OTC products there however can OTC Finished Goods be stored near shipping dock or elsewhere in the warehouse building (which is not compliant to GMP but will be marked off as 'FG Holding Area-Authorized Personnel Only').The firm is a chemical blending firm which is huge manufacturer of institutional products(bulk detergents , cleaners etc) but wants to now move into drug products starting with hand sanitizers etc.
To see if there is future we want to start with just one product in one big room where we mark of areas as production,labeling,packaging etc and quarantine etc and once we get orders etc than we want to go ahead and allot one complete building for manufacturing of GMP products
 
Elsmar Forum Sponsor
T

treesei

#2
Re: "GMP area" definition

We are a multi-facility electronics firm. In one facility (3 story building) we have a whole floor designated for medical device manufacturing. The facility is registered with FDA as a device manufacturer. While we have not had FDA in that overseas facility, we had numerous customer audits. None had any problem with the building designation.

It is also quite common that a warehouse firm stores "GMP" goods and "non'GMP" goods in the same location.

I think the key is effective prevention of product adulteration.

You probably want to consider good segragation in the warehouse, in addition to merely some markers in an open area.

How about the storage of your raw materials? Returned products? Etc.
 
M

MIREGMGR

#3
Your situation won't be operationally different from a small pharma firm renting space in a multi-tenant industrial building, alongside other tenants who are purely industrial.

As Treesai discusses, what matters is not what you call and label your different spaces but how they function, i.e. the completeness of isolation between the regulated and industrial activities.
 
L

lameehan

#4
Our CGMP folks agree with Treesei and Miregmgr; what you have described would qualify as a "GMP area", so long as you've established both a physical environment and a set of procedures that eliminate any possible cross contamination from other areas. The warehouse will require segregated areas to ensure that quarantined, released, and rejected materials are readily identified and that no potential mixing occurs.

Remember that CGMPs require that the procedures you follow to maintain your GMP area be documented in approved Standard Operating Procedures, and that all applicable staff be trained on these approved SOPs. Since you need to document the SOPs anyway, it may make sense to have a 3rd party review your plan to ensure it complies with the regs before you spend a lot of time preparing the physical location.

(There is additional documentation that you'll need to have in place, of course, including raw material specifications, test methods, master batch records, and other required documentation as specified in 21 CFR 211.)
 
Thread starter Similar threads Forum Replies Date
C Calibration Laboratory Location - GMP says in a secure bonded area General Measurement Device and Calibration Topics 5
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
M Europe GMP medical devices - Combination products - Ancillary medicinal substance CE Marking (Conformité Européene) / CB Scheme 4
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
O ISO 13485 vs. GMP - Comparison matrix wanted EU Medical Device Regulations 4
E Preparing for the ASQ CPGP (GMP professional exam), how to revise and remember the vast syllabus? ASQ - American Society for Quality 2
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
K ANVISA B-GMP Auditing requirements for Contract Manufacturers Other Medical Device Regulations World-Wide 1
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
E South Korea, MFDS - GMP inspections Other Medical Device Regulations World-Wide 4
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
A Any recommendation for ASQ's CPGP (Pharmaceutical GMP Professional) Certification exam questions? ASQ - American Society for Quality 2
W Interesting Discussion Class I, GMP Exempt and IEC62304 IEC 62304 - Medical Device Software Life Cycle Processes 2
J Brazil GMP license work with multiple BRH? Other Medical Device Regulations World-Wide 3
I GMP 21 CFR Part 11 Electronic Records Compliance Project Help Qualification and Validation (including 21 CFR Part 11) 9
W EU GMP Annex XI - What is an "appropriate QMS"? Other Medical Device Related Standards 2
S Compliance to Brazil GMP requirements Other Medical Device Regulations World-Wide 12
A Brazil - New RDC 183 - CBPF (GMP) question Other Medical Device Regulations World-Wide 6
L ISO 13485 and European GMP ISO 13485:2016 - Medical Device Quality Management Systems 3
I Moving into Clinical Trials and need to find GMP Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Who can make a Correction of Entry on GMP Records Other Medical Device and Orthopedic Related Topics 1
S Traceability and the initiation of GMP Activities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
A How do we implement a Process Approach ISO 13485:2016 - Existing GMP QMS Other ISO and International Standards and European Regulations 2
J KGMP (Korean GMP requirements) vs. ISO 13485 Other Medical Device Regulations World-Wide 5
R Network/Computer Data Migration Sampling GMP Software Quality Assurance 1
S Could the term "GMP" be used in a Medical Device world? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D I need an example GMP Manual Document Control Systems, Procedures, Forms and Templates 2
V Which SOPs are required by GMP? US Food and Drug Administration (FDA) 2
somashekar GMP (Good Manufacturing Practices) essential information URL Manufacturing and Related Processes 1
S Any suggestions for ASQ CPGP (Certified Pharmaceutical GMP Professional) exam prep? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
J GMP vs Service-Repair Practices - Service Centers Service Industry Specific Topics 2
jkuil Calibration before and after relocation of GMP manufacturing equipment Calibration Frequency (Interval) 7
I GMP?s for Medical Devices in Panama Other Medical Device Regulations World-Wide 1
E Korean GMP Guideline updated to Second Revision - April 2014 Other Medical Device Regulations World-Wide 1
O Implementation of GMP - Technical files for ANVISA Registration Other Medical Device Regulations World-Wide 3
D How to handle a blood stained GMP document ? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 6
0 GMP Guideline for Recycled Plastic Flakes used in Food Applications Quality Manager and Management Related Issues 4
Q FDA and Medical Device Exemptions from GMP Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Good Manufacturing Practices (GMP) for the Aerospace Industry AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R Wooden Pallets in GMP Manufacturing Space Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
AnaMariaVR2 Documentation and Records: Harmonized GMP Requirements Document Control Systems, Procedures, Forms and Templates 1
AnaMariaVR2 FDA GMP Inspectors Cite 70% of Dietary Supplement Firms Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C I am looking for a GMP / HACCP Checklist Quality Manager and Management Related Issues 2
M Revision of Brazilian GMP Regulation - RDC 16/13 (RDC 59 and Portaria 686) Other Medical Device Regulations World-Wide 7
AnaMariaVR2 ANVISA Considers Accepting Foreign GMP Certifications US Food and Drug Administration (FDA) 0
B ANVISA B-GMP Inspection Schedule Other Medical Device Regulations World-Wide 4
somashekar Who can provide a WHO GMP certificate in India acceptable to the CDSCO Other Medical Device Regulations World-Wide 6
S GMP Comparative Information for Canada, US and Europe Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2

Similar threads

Top Bottom