Qualification & Management Of Contract Quality Control Lab - Formats & Templates

v9991

Trusted Information Resource
#1
a COMPREHENSIVE guidance document from
ACTIVE PHARMACEUTICAL INGREDIENTS COMMITTEE (APIC)
includes life cycle management in following four stages.(with respective templeats / chapters)
? Identification of Potential Laboratories
? Risk Assessment
? Quality Assessments
? Ongoing Supplier Management (Monitoring and Evaluation)


just in case if you have not already seen this!!!
 

Attachments

Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
M ISO 14971 Risk Management Qualification of Personnel ISO 14971 - Medical Device Risk Management 5
G RO/DI water system qualification Qualification and Validation (including 21 CFR Part 11) 3
A Qualification of clinical assessment scales EU Medical Device Regulations 1
K Supplier Qualification for Engineering Consultant? Supplier Quality Assurance and other Supplier Issues 3
F Component maintenance qualification - Regulation (EU) No 1321/2014 Article 5 EASA and JAA Aviation Standards and Requirements 6
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
R Qualification list of businesses approved to Off-Shore Aerospace work. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
S Qualification question - ISO 13485 - Setting up a small lab Reliability Analysis - Predictions, Testing and Standards 2
E Qualification for non gmp service providers Supplier Quality Assurance and other Supplier Issues 1
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
DuncanGibbons Understanding the applicability of Design of Experiments to the IQ OQ PQ qualification approach Qualification and Validation (including 21 CFR Part 11) 5
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
K PQ validation qualification - Asked to write a PQ protocol ISO 13485:2016 - Medical Device Quality Management Systems 6
dinaroxentool Question about qualification as a medical device or accessory in Europe EU Medical Device Regulations 2
T Qualification testing of Lead acid batteries Reliability Analysis - Predictions, Testing and Standards 0
Z Qualification of AzureDevOps in Gxp Qualification and Validation (including 21 CFR Part 11) 12
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
D Determining of sample size for 'Operational Qualification' AQL - Acceptable Quality Level 5
B VDA 6.3 Qualification as Process Auditor training course and exam VDA Standards - Germany's Automotive Standards 0
D Performance Qualification per GHTF Guidance Other Medical Device Related Standards 12
M Informational EU – Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 2
dgrainger Informational MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR Medical Device and FDA Regulations and Standards News 0
H How to prepare Performance Qualification (PQ) for autoclave General Measurement Device and Calibration Topics 2
D ISO 13485 - Equipment validation , qualification Qualification and Validation (including 21 CFR Part 11) 6
DuncanGibbons Qualification vs Certification in an Aerospace context AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Z Operational Qualification for Injection Molding Supplier Quality Assurance and other Supplier Issues 6
S AIAG CQI Auditor Qualification and 3rd Party Certification Requirements General Auditing Discussions 2
D FDA Biomarker Qualification Program - Has anyone prepared an application? Medical Device and FDA Regulations and Standards News 0
R Qualification of Distributors such as McMaster-Carr and Digikey to Medical Device Companies ISO 13485:2016 - Medical Device Quality Management Systems 3
xcanals_tecno-med.es Qualification of sterilization indicators as medical devices with the EU MDR 2017/745 EU Medical Device Regulations 7
Z Training Qualification Matrix for ISO 9001:2015 Audit General Auditing Discussions 8
S Internal Auditing for API Spec Q1 - auditor qualification requirements Oil and Gas Industry Standards and Regulations 6
J Qualification of a Software as a Medical Device (SaMD) guidance under MDR EU Medical Device Regulations 9
I Compressed air system qualification and 1 micron particle analysis Other Medical Device Regulations World-Wide 0
S Medical Device Supplier Component Qualification Service Industry Specific Topics 0
O Clean room performance qualification (pq) - How many times can I do each test? Manufacturing and Related Processes 8
K Is Mold qualification / process validation always required? Manufacturing and Related Processes 7
Rameshwar25 IATF ADP - How to proceed for new auditor qualification IATF 16949 - Automotive Quality Systems Standard 17
S Do suppliers of prototyping components need to undergo supplier qualification? ISO 13485:2016 - Medical Device Quality Management Systems 3
P Qualification of weights used for curing epoxy Manufacturing and Related Processes 3
M Qualification of Freezer with IQ and PQ but no OQ Qualification and Validation (including 21 CFR Part 11) 2
S Supplier Qualification - How do we determine which suppliers to qualify? ISO 13485:2016 - Medical Device Quality Management Systems 9
J Installation Qualification (IQ) and Operational Qualification (OQ) for Laser Marking 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 CE Marking (Conformité Européene) / CB Scheme 3
J Simple supplier evaluation qualification process form that includes Risk Assessment Document Control Systems, Procedures, Forms and Templates 2
D What should an ISO 14644 Clean Room PQ (Performance Qualification) look like? Manufacturing and Related Processes 3
P Qualification of a Temperature Controlled Unit have to be empty? Qualification and Validation (including 21 CFR Part 11) 5
R Qualification of Evaluator - Clinical Evaluation Report MEDDEV 2.7.1 Rev 04 Other Medical Device and Orthopedic Related Topics 1
O AS9100 AQMS AEA Qualification Audits 4 Full QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5

Similar threads

Top Bottom