Environmental Monitoring for Biopharmaceutical Manufacturing of Bulk Drug Substances

B

Bad Habit

Hello all,
I am working to qualify a new suite to ISO 14644 standards (in accordance to the white paper changes). In addition to the particulate monitoring, I am adding viable surface and air samples. My plan is to pair every ISO Site requirement in a room with both a viable surface and air site. I will qualify the area at rest (static) for three days than perform dynamic testing for five days. Following incubation and analyzing the results for of the dynamic samples, I hope to reduce the number of sites using a risk based approach. I want to know if anyone else has thought of this. The suit is large and has ISO 5, 7, and 8 locations. The ISO 5 environments will remain as they are, but the 7 and 8 I would like to reduce. Its imperative that I have the ability to reduce the number of sites following qualification, in order to create a sustainable monitoring program. Any thoughts on this are welcomed.

Kind Regards,
Bad Habit
 

Stijloor

Leader
Super Moderator
Re: Environmental Monitoring for Biopharmaceutical Manufacturing of Bulk Drug Substan

A Quick Bump!

Can someone help?

Thank you very much!!
 
Thread starter Similar threads Forum Replies Date
Y Environmental Monitoring in ISO 13485 production areas ISO 13485:2016 - Medical Device Quality Management Systems 2
R Calibration lab environmental monitoring General Measurement Device and Calibration Topics 4
dhuot1990 Issues with REES Environmental Monitoring System Manufacturing and Related Processes 1
C Validation of Applications in a Cloud, CFR 21 part 11 (Environmental Monitoring) Other US Medical Device Regulations 3
M Biological Monitoring Program Environmental Bioburden Test Method Needed ISO 13485:2016 - Medical Device Quality Management Systems 1
R Environmental Monitoring in Pharmaceuticals Manufacturing in EU Benchmarking 2
J Environmental Monitoring Requalifications for Medical Device Industry EU Medical Device Regulations 2
Y Environmental Monitoring - Setting for Particulate Count ISO 13485:2016 - Medical Device Quality Management Systems 3
AnaMariaVR2 Dry & Humid Rooms Environmental Monitoring Systems ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Environmental Monitoring Risk Assessment in NonSterile Pharmaceutical Facility Miscellaneous Environmental Standards and EMS Related Discussions 1
L TSA (Tryptone Soya AGar) plates for environmental monitoring Other Medical Device and Orthopedic Related Topics 6
W Environmental Monitoring - Microbial Identification - Small medical device company ISO 13485:2016 - Medical Device Quality Management Systems 9
J 14001-Looking for some examples of Environmental Aspects and Compliance Obligations/Audits ISO 14001:2015 Specific Discussions 6
J Environmental conditions 60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
S ISO 14001 Operational Planning and Control - Proving evidence of communicating environmental requirements to suppliers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G Suggestions for environmental compliance with small machinists? REACH and RoHS Conversations 1
N How to streamline the search for environmental legislation? ISO 14001:2015 Specific Discussions 1
K ISO 17025 Facilities and environmental conditions SOP ISO 17025 related Discussions 6
B Criteria for evaluating environmental aspects ISO 14001:2015 ISO 14001:2015 Specific Discussions 8
W Non Sterile Medical Device Environmental Tests Other Medical Device Related Standards 4
F Environmental Requirements E-Lab General Measurement Device and Calibration Topics 0
armani Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
S Laboratory Environmental Conditions Outside of limits ISO 17025 related Discussions 4
A How to address Environmental & OHS Opportunities? ISO 14001:2015 Specific Discussions 6
T Advice needed - Environmental MS - unwritten but customer requests policy document ISO 14001:2015 Specific Discussions 5
I Environmental Policy Content - ISO 14001 Clause 5.2 ISO 14001:2015 Specific Discussions 2
K How to verify the Storage and Transport environmental condition for Medical Device Miscellaneous Environmental Standards and EMS Related Discussions 3
D Templates for Environmental, Safety and quality Management System wanted Document Control Systems, Procedures, Forms and Templates 3
M What is Environmental intelligence specific to IVDs or Medical devices? Miscellaneous Environmental Standards and EMS Related Discussions 1
A Environmental Management System Lead Auditor Competence ISO 14001:2015 Specific Discussions 2
W Organizational Responsibility for Environmental Compliance of Products REACH and RoHS Conversations 4
M PDCA cycle - Process mapping - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 1
V Environmental aspects in a bank ISO 14001:2015 Specific Discussions 7
C Legal or Regulatory Requirements as identified in our Environmental Aspects ISO 14001:2015 Specific Discussions 9
R India - EMS 14001:2015 Environmental product declarations ISO 14001:2015 Specific Discussions 2
S Question about environmental control - Pest control management procedure ISO 13485:2016 - Medical Device Quality Management Systems 8
A Difference between Environmental Impact and Risk ISO 14001:2015 Specific Discussions 7
R Excel Dashboard for Health Safety and Environmental KPI's for Multiple Sites Occupational Health & Safety Management Standards 3
L Environmental Gas Leak Detection Equipment Recomendations Miscellaneous Environmental Standards and EMS Related Discussions 2
G Sample size for IEC 60601-1-11 environmental tests IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
R ISO 14001 Environmental targets - Office only ISO 14001:2015 Specific Discussions 9
T Guidance - Setting up an integrated quality & environmental management system Career and Occupation Discussions 12
V Looking for a consolidated Manual for QMS, FSMS and Environmental system Food Safety - ISO 22000, HACCP (21 CFR 120) 1
V Looking for a Supplier Evaluation template for Environmental Performance Miscellaneous Environmental Standards and EMS Related Discussions 1
R Mobile Auto Valeting Services - Waste Disposal (Environmental Perspective) Miscellaneous Environmental Standards and EMS Related Discussions 3
G Supplier Significant Environmental Aspects - Audit Finding ISO 14001:2015 Specific Discussions 21
U HSE (Health, Safety and Environmental) Documents and Documentation Occupational Health & Safety Management Standards 1
S MIL-HDBK-217 - Understanding the various Environmental Conditions Reliability Analysis - Predictions, Testing and Standards 1
somashekar Industry examples of Significant Beneficial Environmental Impacts Miscellaneous Environmental Standards and EMS Related Discussions 3
G ISO 14001 & Product Design Process Environmental Aspect Review Requirements ISO 14001:2015 Specific Discussions 7

Similar threads

Top Bottom