QMS for Medical products & Pharmaceutical Drugs in one facility

#1
We are looking to manufacture products like nasopharyngeal and oral specimen collection swabs, IVD tests and reagents at our facility and would like to understand the certifications needed and see if we can possibly find someone who could work with us in writing the SoPs necessary to get the certifications and to be compliant with FDA.

Apart from this, we also want to repackage oral pharmaceutical drugs and set up a sterile ophthalmic solution manufacturing capability as well. What are the clean room standards needed for these. Do we have to set up separate clean rooms for each activity?

We are located in Garden Grove, California.
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#2
That sounds like quite an undertaking! Is there an existing business there, and what do you do there now?

It might be possible to use the same clean room, but you must have designated areas in which the different activities take place.

You will need a quality system that complies with all relevant parts of the code of federal regulations.

Anyone else have that Sublime song in their head now?
 
Last edited:
#3
Yes, we have an existing manufacturing business here for blending, filling & finishing for surface disinfectants and wipes. the facility is about 150K sqft, most of it being used for warehouse/storage currently, we have the flexibility to expand the manufacturing activities here so the plan is to add large clean room areas for the new planned products.
 
Thread starter Similar threads Forum Replies Date
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
JoCam Certified QMS for MDR - Class I medical device manufacturers EU Medical Device Regulations 8
U QMS for medical device startups ISO 13485:2016 - Medical Device Quality Management Systems 26
R ISO 13485 and QMS related concepts Training - Small medical device startup company ISO 13485:2016 - Medical Device Quality Management Systems 9
J Medical Devices in Japan - Conformity of QMS to ISO 13485 Japan Medical Device Regulations 1
A QMS - Medical Device - New company under a current one ISO 13485:2016 - Medical Device Quality Management Systems 3
A Determining Retention Period for Medical Device QMS documents Document Control Systems, Procedures, Forms and Templates 5
Q QMS Software for Startup Medical Device Company Other Medical Device and Orthopedic Related Topics 7
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
somashekar Electronic data Back-up procedure, for Medical device QMS and regulatory purpose. ISO 13485:2016 - Medical Device Quality Management Systems 4
D Where to buy "canned" Medical Device QMS Procedures and Documents IEC 62304 - Medical Device Software Life Cycle Processes 12
J General QMS questions in regard to Medical Software ISO 13485:2016 - Medical Device Quality Management Systems 8
sagai Role and Use of Non QMS Standards and Guidances in the Medical Industry 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 17
bio_subbu GHTF Issues - Medical Devices - Guidance on CAPA and related QMS processes Other Medical Device Related Standards 1
D Medical Devices Company QMS Software - Recommendation for an off the shelf software ISO 13485:2016 - Medical Device Quality Management Systems 13
A Auditing a Medical Device Subcontractors QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
G Costs associated with setting up new medical device QMS ISO 13485:2016 - Medical Device Quality Management Systems 4
M Justifying Subcontractor (with no QMS) Service - Class 1 Medical Instruments ISO 13485:2016 - Medical Device Quality Management Systems 10
C Medical Device QMS manual - MDD, AIMD, 21 CFR part 820, CMDCS, and the new ISO 13485 Quality Management System (QMS) Manuals 3
R ISO 13485 Medical Devices QMS - Requirements for Regulatory Purposes Checklist ISO 13485:2016 - Medical Device Quality Management Systems 26
M Options when MSA acc. to VDA 5 is NOK (Qms > 30%) Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
D QMS Realignment after business splits into 2 different companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
G One-person QMS - possible? ISO 13485:2016 - Medical Device Quality Management Systems 18
A SaaS SaMD - Impact QMS ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO9001 QMS: Quality Manual Examples & Templates ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
qualprod Can a consultant be audited instead of QMS responsible? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Do you follow your QMS for non-device software features? Medical Information Technology, Medical Software and Health Informatics 4
Ed Panek How to address a QMS Entry Error ISO 13485:2016 - Medical Device Quality Management Systems 8
D Digital Healthcare - QMS requirements Other US Medical Device Regulations 3
BeaBea QMS/ Training Management Software Service Industry Specific Topics 4
C First Round of QMS Internal Audits - Ethical Dilemma Internal Auditing 7
N Handling B-Grade Products within the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
M Supplied Goods out of QMS / DtS? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Can outsourced processes be excluded from QMS scope? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 6
S Implementation of QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Correcting Electronic QMS Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
M Are We Ready for a QMS? Quality Management System (QMS) Manuals 8
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Quality Objective for QMS prior to Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
V Remote QMS Coordinator Position Job Openings, Consulting and Employment Opportunities 6
A How to prepare QMS manual for purchasing department Quality Management System (QMS) Manuals 5
GreatNate Master Control QMS software Quality Tools, Improvement and Analysis 1
GreatNate Anyone using the Intellect QMS software? Quality Assurance and Compliance Software Tools and Solutions 1
A Electronic forms QMS Document Control Systems, Procedures, Forms and Templates 12
supadrai Remote Opportunity - Large Scale Glove Factory QMS / RA / Legal Job Openings, Consulting and Employment Opportunities 0
C Retention of QMS Plans and Reports ISO 13485:2016 - Medical Device Quality Management Systems 5
Q New QMS...Old Projects ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom