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

Qvents – Discussion forum for Pharma Quality events, Regulatory Actions

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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Popular: Warning Letters, Recalls

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FDA Warning Letter to Simtra Biopharma Flags Microbial Controls, Integrity Failures, Design Issues
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USFDA Issues Guidance for Impurity Specifications for Semi-Synthetic & Fermentation Antibiotics

The USFDA has issued a draft guidance for Establishing Impurity Specifications for Antibiotics in April 2026. This guidance is applicable

April 21, 2026 No Comments

Responding to FDA Form 483: USFDA Issues Guidance

The USFDA has released a draft guidance titled “Responding to FDA Form 483 Observations at the Conclusion of a Drug

April 2, 2026 No Comments

Qvents Apps and Tools For QMS and GMP Processes

Qvents provides useful tools for QMS processes – Risk Assessments, Continuous Process Validations, Supply Chain Traceability Mapping of Drug Products. The Apps

February 17, 2026 2 Comments

Unichem Recalls Hypertension Tablets for Nitrosamine Impurity

Unichem Pharmaceuticals (USA), Inc. initiated a recall of Bisoprolol fumarate and Hydrochlorothiazide tablets in the US in January 2026 due

February 16, 2026 7 Comments

USFDA 483 to Pharmathen Flags Deficient Aseptic Operations

USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form 483 with nine observations. The

February 5, 2026 12 Comments

Imprimis Recall Unapproved Ophthalmic Injections for Glass Particulates in US

Imprimis NJOF recalled three intraocular ophthalmic injection drug products in December 2025 (as per USFDA Enforcement Reports) in the United

January 5, 2026 8 Comments

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Digital platform for Pharma TechOps professionals: Pharma GMP News, Quality & Regulatory Events, Warning letters & USFDA 483s, Product Recalls, Guidelines, Discussion Forums, Trainings, Pharma Jobs, Networking

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 …Come alive with your expertise and knowledge

Warning letters

USFDA 483s

Product Recall

Discussion forum

User Profiles Page

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.

Pharma Jobs

Browse Pharma job openings. Search jobs with key words. Register your profile in Qvents and Search for Jobs matching your profile.

Pharma Job Listing / Employers

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Pharma Job Listing

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From the Tags page pick the Tags and Click Submit to get content matching selected Tags:

FDA Auditors, Audit Citing’s, Regulatory Events, Recalls & Reasons, Regulatory Agencies…

Qvents Apps & Tools

Nitrosamines Risk Assessment for APIs, Excipients, Drug Products, Continuous Process Validation (CPV) & Control Charts, Supply Chain Mapping….

Open the Apps, Fill in the forms, Get the results with maps, charts, recommendations…
The apps & tools are designed to comply with the regulatory guidance. Contact Qvents for any support.

Quality Insights, Templates

Often regulatory requirements and guidances are very generic, broad based with minimum practical implementation guidelines.

Qvents Quality Insights present practical approaches for implementation of the regulatory guidances with user-friendly documentation templates

Qvents Posts

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USFDA Issues Guidance for Impurity Specifications for Semi-Synthetic & Fermentation Antibiotics

April 21, 2026 No Comments

Responding to FDA Form 483: USFDA Issues Guidance

April 2, 2026 No Comments

Qvents Apps and Tools For QMS and GMP Processes

February 17, 2026 2 Comments

Qvents Forums

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Ivermectin 12mg – Oral Antiparasitic Care for Infection Relief

genericusa

3 weeks ago

APIs & Intermediates

27 Views

0 Likes

0 Replies

Future of API Manufacturing in India

pharmatheon

3 months, 1 week ago

APIs & Intermediates

71 Views

0 Likes

0 Replies

Excipient Risk Assessment-EUGMP

QueriesQvents

4 months, 2 weeks ago

Excipients

108 Views

0 Likes

0 Replies

Supply Chain Traceability Mapping – EUGMP

Venkitesh TK

4 months, 2 weeks ago

Materials, Supply chain

102 Views

0 Likes

0 Replies

Method Transfer USFDA 483

Qvents Team

7 months, 1 week ago

Methods, Validations

178 Views

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Guidelines

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API DMF (Drug Master File)

Clean Rooms & HVAC Systems

Cleaning Validation

Computer systems validation (CSV), Electronic Data Controls

Controlled Correspondence / Scientific Advice with regulatory agencies

Data Integrity

Excipients related

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

Pharma Jobs

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DQA Manager
Syngene International Ltd
Junior Team Member – Microbiology
Cipla

Qvents: Pharma Information, learning and knowledge platform

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

Qvents Learning Resources

Pharma Jobs

Browse Pharma job openings. Search jobs with key words. Register your profile in Qvents and Search for Jobs matching your profile.

Pharma Job Listing / Employers

List your Job Openings with Qvents; Search for profiles matching the jobs requirements; View profiles, Connect with candidates.

Subscribe to Qvents.

Get email updates on new Posts, News, new Forum Discussions & Topics.

Update your profile at Qvents. Search for Jobs matching your profiles.
Updating your profile helps in networking with Industry peers. Helps Employers to find your profile and connect with you