APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient Plants European Medicines Agency (EMA) : Guideline on setting health based exposure limits; Questions and answers on Guideline on setting health-based exposure limits USFDA Guide To Inspections : Validation Of Cleaning Processes PIC/S : Guideline On Setting Health Based Exposure Limits For Use In Risk Identification In The Manufacture Of Different Medicinal Products In Shared Facilities (PI 046-1 Annex 1 July 2018) TGA : Cleaning Validation – A regulatory perspective (Presentation) WHO TRS 1033 – Annex 2 : Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

USFDA Data Integrity and Compliance with Drug CGMP Questions and Answers – USFDA Guidance for Industry EMA (European Medicines Agency) Data Integrity Aug 2016 (European Medicines Agency) MHRA (Medicines & Healthcare products Regulatory Agency) ‘GXP’ Data Integrity Guidance and Definitions WHO TRS 1033 – Annex 4 : WHO Guideline on Data Integrity PIC/S Guidance on Data Integrity ; Good Practices For Data Management And Integrity In Regulated Gmp/Gdp Environments Comparison of EMA and FDA Guidance on Data Management and Data Integrity; Barbara W. Unger; Redica Systems Data Integrity checklist by Agilent (Useful checklist).

Excipient Risk Assessment (Europe) : Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use ( EC 2015/C 95/02) PIC/S Document: Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use

APIC (Active Pharmaceutical Ingredients Committee): Guidance On Aspects Of Cleaning Validation In Active Pharmaceutical Ingredient Plants European Medicines Agency (EMA) : Guideline on setting health based exposure limits; Questions and answers on Guideline on setting health-based exposure limits USFDA Guide To Inspections : Validation Of Cleaning Processes PIC/S : Guideline On Setting Health Based Exposure Limits For Use In Risk Identification In The Manufacture Of Different Medicinal Products In Shared Facilities (PI 046-1 Annex 1 July 2018) TGA : Cleaning Validation – A regulatory perspective (Presentation) WHO TRS 1033 – Annex 2 : Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation

USFDA Data Integrity and Compliance with Drug CGMP Questions and Answers – USFDA Guidance for Industry EMA (European Medicines Agency) Data Integrity Aug 2016 (European Medicines Agency) MHRA (Medicines & Healthcare products Regulatory Agency) ‘GXP’ Data Integrity Guidance and Definitions WHO TRS 1033 – Annex 4 : WHO Guideline on Data Integrity PIC/S Guidance on Data Integrity ; Good Practices For Data Management And Integrity In Regulated Gmp/Gdp Environments Comparison of EMA and FDA Guidance on Data Management and Data Integrity; Barbara W. Unger; Redica Systems Data Integrity checklist by Agilent (Useful checklist).

Excipient Risk Assessment (Europe) : Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use ( EC 2015/C 95/02) PIC/S Document: Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use

Posts Page – Qvents

Q: Controlled Correspondence / Scientific Advice with regulatory agencies

USFDA Controlled Correspondence Related to Generic Drug Development USFDA Guidance Document – Controlled Correspondence Related to Generic Drug Development – Draft Guidance. Cover Letter Attachments for Controlled Correspondences and ANDA Submissions – Guidance WHO Prequalification – Technical Advice ; Advice to Manufacturers EMA – Scientific advice and protocol assistance

Qvents

Discussion forum for Pharma Quality events, Regulatory Actions

Warning letters, 483s, Recalls, Import Alerts, Audit observations

Discussion forum for Pharma Quality events, Regulatory actions (Warning letters, Recalls, 483s, Import alerts; Deviations, OOS, Complaints) and other Pharma Tech Ops topics

Qvents Knowledge sharing & learning platform

Qvents is a knowledge sharing platform focussed on Pharma Quality Systems, GMP and Regulatory topics. Qvents discusses different quality and regulatory events, what causes such events, what companies can do to prevent such events. You can post your comments and replies, seek clarifications and start new discussions. View what industry is doing, learn from industry professionals, peers and seniors, use the learnings for training, development, adopt for enhancing the systems and processes.

Qvents …Come alive with your expertise and knowledge

Qvents focusses on Pharma Quality Events (Qvents), Regulatory observations and actions. You can participate in discussions, contribute your ideas and perspectives, Qvents is a powerful medium where your expertise and knowledge on the subject can come alive, get peer reviewed & commented and get noticed…

Warning letters

USFDA Warning letters are discussed, with analysis of key deficiencies and observations, what can lead to the observations, what you should have in place to meet agency expectations and prevent such observations and evets at your site, company. Read, give your comments, seek clarifications and use the discussions for trainings and audit readiness at your facility.

USFDA 483s

Published USFDA 483s (Inspectional observations issued at the close of inspections) are reviewed and discussed focussing on what can lead to such observations, what you should have in place to meet agency expectations and prevent such observations at your manufacturing site. You can identify the inspector focus, review the post and comments, reply and seek clarifications and use the discussions for trainings and audit readiness at your facility.

Product Recall

Product recalls are cumbersome to execute and close, invite regulatory attention, leads to loss of reputation and harm the patient population if not executed adequately. The product recall posts discusses recalls due to GMP issues focussing on what can lead to such events, and what companies should have in place to prevent such events at the facilities

Discussion forum

Discussion forums on Pharma Tech Ops, Quality, regulatory topics..Post your queries and comments on various topics, learn from industry peers..For the pharma professionals to learn and grow together for better quality and better compliance

Check out the Guidelines page for comprehensive list of guidelines and updates, Learning Resources page for upcoming and archived Trainings and Webinars, News page for latest news on Pharma Quality and regulatory news.

User Profiles Page

Update your profile, get noticed. All your posts, comments, replies can also be viewed from your profile page and you control what others can view and cannot view. Search for profiles of Qvents users, view the profiles, proficiencies and expertise and connect. A great way for Pharma industry to professionals to get noticed and connected!!!

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Guidelines

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API DMF (Drug Master File)

Clean Rooms & HVAC Systems

Cleaning Validation

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Data Integrity

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Excipient Risk Assessment (Europe): Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use ( EC 2015/C 95/02)
PIC/S Document: Guidelines On The Formalised Risk Assessment For Ascertaining The Appropriate Good Manufacturing Practice For Excipients Of Medicinal Products For Human Use

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Qvents: Pharma Information, learning and knowledge platform

Qvents publish news and expert review posts on Pharma Quality & Regulatory events, Warning letters, 483s, alerts, recalls, enforcement actions; Deep review of What causes the events, What should be in place to prevent such events, Actions & CAPAs.

Be informed about current concerns and focus areas of regulators and auditors; Share your views, comments, hear from industry peers….

Qvents Forums

Discussion forums on Pharma GMP, Quality, Regulatory, TechOps topics – Create your Topics, Post your Queries, Join discussions on current Topics in the Forum, post your comments!!!

Pharma Guidelines

Access the most UpToDate Pharma Quality, Regulatory, Technical Guidelines / Guidances from different agencies; All related guidelines on each topic from different agencies at one place (USFDA, EDQM, EMA, WHO, TGA, ICH, Professional bodies like ISPE, PDA and others)

Qvents Learning Resources

Qvents list select Learning Resources - Trainings, Webinars, Seminars, Conferences from different agencies, professional bodies, organisations, SMEs and Experts. Register for upcoming events; View past events from archives.

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