Overview of ISO 19011:2018 Guidelines for Auditing Management Systems

06/11/2018 10:42
Overview of ISO 19011:2018 Guidelines for Auditing Management Systems

FDA publishes revised MAPP, ANDA Suitability Petitions (5240.5)

10/08/2018 23:17
Today, August 10, 2018, the FDA published a revision to the Manualof Policies and Procedures (MAPP 5240.5), " ANDA Suitability Petitions."This MAPP establishes the policies and procedures for respondingto a suitability petition submitted to the FDA Office of Generic Drugs by or onbehalf of...

FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancy

10/08/2018 23:13
FDA allows marketing of first direct-to-consumer app for contraceptive use to prevent pregnancyTheU.S. Food and Drug Administration permitted marketing of the first mobilemedical application (app) that can be used as a method of contraception toprevent pregnancy. The app, called Natural Cycles,...

Brexit preparedness: EMA to further temporarily scale back and suspend activities

08/08/2018 23:59
 Next phase of business continuity plan aimed at securing essential public and animal health activitiesThe European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core...

FDA Launches New Medication Guide Database - Drug Information Update

08/08/2018 23:46
FDA has launched a new Medication Guide database to replace the current Medication Guide web page. Medication guides are provided with many prescription medicines. A Medication Guide is a form of patient labeling that is part of the FDA-approved prescription drug labeling. Medication Guides address...

FDA issues final guidance entitled Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances

08/08/2018 23:38
Today FDA published a guidance for industry entitled Dissolution Testing and Acceptance Criteria forImmediate-Release Solid Oral Dosage Form Drug Products Containing HighSolubility Drug Substances.   This guidance has been developed toprovide manufacturers with recommendations for...

Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products

05/08/2018 00:06
Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products               

Seetharam Kandarpa Receives ASQ-Certified Manager of Quality/Organizational Excellence

24/05/2018 22:18
Milwaukee, Wis., 09/12/2017 — The Certification Board of ASQ is pleased to announce that Seetharam Kandarpa has completed the requirements to be named an ASQ-Certified Manager of Quality/Organizational Excellence, or ASQ CMQ/OE. As such, Seetharam Kandarpa has reached a significant level of...

Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP)

28/05/2017 14:47
Overview of ASQ Certified Pharmaceutical GMP Professional (CPGP) 

Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017

21/05/2017 12:00
Web Series Session 1: Overview of ASQ Certified Quality Auditor conducted on 21 May 2017

Mentoring Classes for ASQ-CQA

08/05/2017 23:14

Mentoring Class for ASQ-CQA and ASQ-CPGP

23/04/2017 22:10

Regulatory information - adjusted fees for applications to EMA from 1 April 2017

23/04/2017 18:48
Fees adjusted to 2016 inflation rateGeneral, non-pharmacovigilance fees payable to the European Medicines Agency by applicants and marketing-authorisation holders are increasing by 1.2% on 1 April 2017.Full details of the new fee levels are available in Commission Regulation (EU) No 2017/612...

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017

23/04/2017 18:47
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017Eleven medicines recommended for approval, including four orphansThree recommendations on extensions of therapeutic indicationsWithdrawal of applicationOthersFor completehighlights, ClickHere.

Recognition of Alternative Compendia (BP/EP/JP) by the FDA

23/04/2017 18:43
The Office of Pharmaceutical Quality within FDA's Center for Drug Evaluation and Research (CDER) published a new edition of the document "MAPP (Manual of Policies and Procedures) 5310.7 - Acceptability of Standards from Alternative Compendia (BP/EP/JP) on 30 January 2017. The main change to the...

EMA revises Guide on Pharmaceutical Water

23/04/2017 18:40
According to the European Pharmacopoeia, it will be allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods (as already reported under "WFI obtained by non-distillation methods - What are the Next Steps?"). Now, the European Medicines Agency...

GCP - Implementing Regulation on Inspection Procedures

23/04/2017 18:37
The Implementing Regulation (EU) 2017/556 of 24 March 2017 on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 was published on 25 March 2017 in the Official Journal of the European Union. With it, Article 63 of the GCP...


23/04/2017 18:37
The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website.Question 8 regarding contractual arrangements with vendors for electronic systems under "GCP matters" Q&A  (please see below) has been published in January 2017...

MHRA's Interpretation of Cross Contamination & PDEs

23/04/2017 18:36
The British inspectorate MHRA has recently published an interpretation that goes into detail on the use of health based exposure limits and explains the cases where EMA's new concept can be applied. One essential element of that concept is EMA's Q&A Paper describing when a product should be...

Packaging: Pharmeuropa Draft Chapters regarding PVC

23/04/2017 18:34
A draft of Ph. Eur. chapter 3.1.13. Plastic additives has been published for comment in Pharmeuropa 29.2. The chapter has been revised following the identification of di(2-ethylhexyl)phthalate as a substance of very high concern (SvHC) according to the criteria of Article 57 of regulation (EC)...

Best Practice Guide for Quality Agreements published

02/02/2016 23:58
In the EU GMP Guide Chapter 7 on Outsourced Activities, expectations regarding quality contracts are clearly defined. In the US, not much detail was provided so far. In 2013, the U.S. Food and Drug Administration (FDA) has published the draft Guidance for Industry "Contract Manufacturing...

ISO 14644 - Part 1: Final Version on Cleanroom Classification

02/02/2016 23:54
Part 1 of ISO 14644 entitled "Classification of air cleanliness by particle concentration" is one of the most  important norms in the GMP environment as it is the only technical norm which is directly referred to in an official GMP guideline document: the currently applicable Annex 1...

Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances

02/02/2016 23:50
A chemical structure with a therapeutic moiety for which no authorisation dossier has been submitted so far and which is - from a chemical structure point of view - not related to any other authorised substances is per se a "NAS" (New Active Substance). But what about a...

Training Presentation on 'ICH Q9: Quality Risk Management'

20/09/2015 10:10
Dear Friends!I made a training presentation on 'ICH Q9: Quality Risk Management'.I hope it is useful to all Pharmaceutical GMP professionals and Quality Auditors to understand basic principles of quality risk management and application of various risk assessment tools...

Training Presentation on 'ICH Q10: Pharmaceutical Quality System'

20/09/2015 09:54
Dear Friends!I made a training presentation on ICH Q10: Pharmaceutical Quality System.I hope it is useful to all Pharmaceutical GMP professionals to understand pharmaceutical quality system along with GMP for manufacturing of pharmaceutical products.ICH Q10: Pharmaceutical Quality...

Training presentation on 'How to conduct an effective internal quality audit'

20/09/2015 09:48
Dear Friends!I made a training presentation on 'How to conduct an effective internal quality audit'.I hope it is useful to all Pharmaceutical GMP professionals and Quality Auditors to understand auditing principles, requirements and management process (with reference to ISO 19011) along...

IPEC Federation Published Position Paper on Third Party Audit and Certification Programmes

20/09/2015 08:02
IPEC Federation PublishedPosition Paper on Third Party Audit and Certification Programmes Problem statement:Pharmaceutical manufacturers are facing increased regulatorydemands to ensure that the raw materials used in their medicines - includingexcipients - are safe, of high-quality, and...


20/09/2015 07:55
WHO Draft Guidance on "Supplementary guidelines ongood manufacturing practices for heating, ventilation and air-conditioningsystems for non-sterile pharmaceutical dosage forms"·        BackgroundDuringthe consultation on data management, bioequivalence, GMP...

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

20/09/2015 07:49
This integrated version has been created for printing purposes only.Please refer to the individual question & answers as published in thepre-submission guidance for access to the hyperlinked information. Questions and answers are being updated continuously, and will bemarked by "NEW" or "Rev."...

Consultation on EU GMP Guidelines, revised Annex 17 on the Real Time Release Testing

20/09/2015 07:44
On15/09/2015, DG SANTE launches a consultation on the revision of Annex 17: RealTime Release Testing.Stakeholders - and other interested parties - are invited to comment on this consultation document.Commentsshould be sent at the latest by 11 December 2015 by e-mail to:...

New GMP Implementing Act published by EU

20/09/2015 07:41
The EU Commission haspublished a new public consultation on an Implementing Act on Principles and guidelineson good manufacturing practices for medicinal products for human use.The reason is that once Regulation(EU) No 536/2014 on clinical trials becomes applicable, manufacture and importof...

APIC revised the "How to do" Document on ICH Q7

20/09/2015 07:35
Shortlyafter the entry into force of the Good Manufacturing Guide for Active Pharmaceutical IngredientsICH Q7 in the year 2000 the Active Pharmaceutical Ingredients CommitteeAPIC wrote the "How to do" document which clarifies the requirementsof the guideline on the basis of experience gained from...

EDQM released new edition of Technical Guide for the Elaboration of Monographs

09/09/2015 23:29
At its 152nd sessionthe European Pharmacopoeia Commission approved thepublication of a new edition of the Technical Guide for the elaboration ofmonographs. This guide is an essential tool for the drafting of monographsbut also for the transposition of analytical techniques and parameters into...

Quality Metrics: Industry Reaction to FDA's Draft Guidance

09/09/2015 23:15
On Monday, the US Food and DrugAdministration (FDA) held a public meeting to discuss its plan to requestquality metrics from drug manufacturers. The meeting was the first opportunityfor the agency and industry to publicly discuss the plan since FDA released itsdraft guidance in July.While many...

Recent Non-compliance Reports Published by EudraGMDP

28/07/2015 22:27
Recent non-compliance reports published by EudraGMDP:PARABOLIC DRUGS LIMITED (India)- Issued on 28 July 2015WUXI JIDA PHARMACEUTICAL CO., LTD (China)-  Issued on 28 July 2015JINAN JINDA PHARMACEUTICAL CHEMISTRY CO., LTD. (China)-  Issued on 28 July 2015INTEGRA LIFE SCIENCES CORP (US)-...

New Draft Guidance from USFDA on 'Request for Quality Metrics

28/07/2015 21:55
This guidance document is being distributed for comment purposes only. Comments andsuggestions regarding this draft document should be submitted within 60 days ofpublication in the Federal Register of the notice announcing theavailability of the draft guidance. Submit electronic comments to...

Update of Guideline on the packaging information of medicinal products for human use authorised by the Union (July 2015) [EudraLex - Volume 2]

28/07/2015 21:16
EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal products for human use.Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory...

New final Guidance from USFDA related to Pharmaceutical Quality/CMC on 'Analytical Procedures and Methods Validation for Drugs and Biologics

28/07/2015 21:05
Introduction: This guidance supersedes thedraft of the same name that published on February 19, 2014 (79 FR 9467) andreplaces the 2000 draft guidance for industry on Analytical Procedures and MethodsValidation and the 1987 Guidelines for Submitting Samples and Analytical Datafor Methods...

USFDA published a final rule (FDA-2011-N-0898 Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products)

28/07/2015 20:10
Drugshortage has become a serious problem. Besides problems in the distributionchain, reasons could be manufacturing and quality problems, delays, anddiscontinuations. The U.S. Food and Drug Administration (FDA) takes more andmore efforts to address and prevent drug shortages. In the case of...

Notice by CDSCO regarding administrative action by concerned licensing authority (Dated 04/06/2015)

14/06/2015 16:08
A notice was released recently by DCGI regarding following anequivalent administrative action, taken by licensing authority of otherconcerned country, in India also. A detailed assessment of impact due to this notice may be required to carry outby Indian Pharmaceutical industry.Notice

New WHO TRS 992 (May 2015) having guidance on Hold time study, Process validationand stirage & transport of products

14/06/2015 15:58
WHO TRS (T e c h n i c a l  R e p o r t  S e r i e s) 992 was released in May-2015 by WHO. This TRS has someuseful guidelines on the following topics as annexure. Out of these annexure,annex 3 (Guidelines on good manufacturing practices: validation, Appendix 7: non‑sterile process...

USFDA Draft Guidance on "Conditions: Reportable CMC Changes for Approved Drug and Biologic Products" Effective from 29 May 2015

02/06/2015 23:59
INTRODUCTION: This guidance has been developed to address the lackof clarity with respect to what chemistry, manufacturing, and controls (CMC)information in a marketing application constitutes an established condition ora "regulatory commitment" that, if changed following approval,...

USFDA Guidance on "ANDA Submissions- Refuse-to-Receive Standards" Effective from 26 May 2015

02/06/2015 23:53
 INTRODUCTION: This guidance is intended to assist applicants preparing to submitto FDA abbreviated new drug applications (ANDAs) and prior approval supplements(PASs) to ANDAs for which the applicant is seeking approval of a new strengthof the drug product. The guidance highlights...

FDA and CMS Form Task Force on LDT Quality Requirements

17/04/2015 22:35
FDA and CMS Form Task Force on LDT Quality Requirements

U.S. Marshals seize unapproved drugs from Florida distributor

17/04/2015 22:31
U.S. Marshals seize unapproved drugs from Florida distributor

FDA's New Pharmaceutical Quality Approach- One Quality Voice

17/04/2015 22:11
The launch of the Center for Drug Evaluation and Research (CDER) Office of Pharmaceutical Quality (OPQ) is a milestone in FDA's efforts to assure that quality medicines are available to the American public. As a new super-office within CDER, OPQ is strategically organized to streamline regulatory...

Health Canada Launched New Drug and Product Inspections Database

16/04/2015 23:30
Minister Ambrose Launched New Drug and Health Product Inspections Database, UnderlinesCommitment to TransparencySearchabletool makes it easy to find details on inspections of drug companiesApril13, 2015 - Ottawa, ON - Health CanadaHealthMinister Rona Ambrose launched the Drugand Health Product...

TGA finalised the specificationfor the Australian eCTD format submissions

16/04/2015 23:25
The Australian TherapeuticGoods Administration (TGA) has released, on 14 April 2015, the first final specification for the Australian eCTD. Since late 2014 the TGA wasaccepting eCTD submissions based on draft specification 0.9 in a pilot phase to assess the eCTD readiness of the agency and industry...

WHO Called for Increased Transparency in Medical Research

16/04/2015 22:34
14 APRIL 2015 ' GENEVA - WHO issued a public statement calling for the disclosure of results from clinical trials for medical products, whatever theresult. The move aims to ensure that decisions related to the safety andefficacy of vaccines, drugs and medical devices for use by populations...

Indian Government to amend SCHEDULE Y of D&C Rules pertaining to authenticity of data submitted by applicants

16/04/2015 21:38
The Union HealthMinistry will soon amend the Note under Schedule Y (REQUIREMENTSAND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FORSALE OR TO UNDERTAKE CLINICAL TRIALS) of the Drugs and CosmeticsRules, 1945 regarding the authenticity of the data or documents submitted...

FDA warns consumers not to use muscle growth product called Tri-Methyl Xtreme

16/04/2015 21:21
Product marketed as a dietary supplement contains potentially harmful synthetic steroids  April 13, 2015 The U.S. Food and Drug administration is warning consumers to stop using a dietary supplement for muscle growth linked to serious liver injury.Tri-Methyl Xtreme, distributed by Las...

Final EU GMP Annex 15 Qualification & Validation- Effective from 01 October 2015

03/04/2015 00:09
"On the 30th of March, the EU released its updated version of Annex 15 Qualification and Validation which will be effective on 01 October 2015. In this article, the changes between the draft version and the revised Annex 15 version are discussed. When the draft was released, there was a...

GMP Pre-Inspection Compliance Documents published by MHRA

03/04/2015 00:06
The MHRA has published a revised set of documents which are part of the risk based inspection system of the GMP Inspectorates in the UK. The MHRA has established a system in which companies have to fill out documents about their current compliance status. These documents are intended to help MHRA...

Revision of GMP Data Integrity Definitions from MHRA

03/04/2015 00:02
Medicines, medical devices and blood regulation and safety – guidance Good manufacturing practice: data integrity definitions Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry. Document: Revision 1.1...

New Guidance on Environmental Assessments for Biotechnology Products by USFDA

03/04/2015 00:01
  USFDA Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products   Background   Under 21 CFR 25.40 of the Code of Federal Regulations, most pharmaceutical...

EU Commission released two final Guidelines on GMP for Excipients and GDP for APIs

03/04/2015 00:00
After nearly two years of consultation, the European Commission has published two important and long-awaited guidelines in the official journal of the European Union, edition 21st March 2015:   The "guidelines on the principles of good distribution practice for active substances of medicinal...

Health Canada Vanessa's Law, effective from November 2014

03/03/2015 00:24
Introduction: Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) Amendments to the Food and Drugs Act (Bill C-17)   On December 6, 2013, the Government of Canada introduced the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). On November 6, 2014 it...

EudraLex V30 - January 2015

14/02/2015 13:18
   Now, you can consult the whole Pharmaceutical Legislation (Human and Veterinary) with an integrated search engine.The Eudralex V30 is similar to the EudraLex section of this web site, but it can be used off-line with the search engine. All the documents are in.pdf...

USFDA Warning Letters- Drugs Updates

14/02/2015 13:11
Apotex Research Private Limited: Labs Limited:

Man gets 3-year prison sentence for fake drug study

14/02/2015 13:06
A clinical drug trial coordinator - who used his own stool samples for a drug study and pocketed the money earmarked for stool donors - received a three-year prison sentence in federal court Tuesday.Assistant U.S. Attorney Maureen Merin recalled in court how Wesley McQuerry, 50, created fake...

MHRA Warns of People Impersonating its Staff

14/02/2015 13:02
News storyImpersonation of MHRA staffFrom:Medicines and Healthcare Products Regulatory AgencyFirst published:11 February 2015Part of:Protecting patients from avoidable harm, National Health Service and Public health We are aware of telephone calls made to a company recently from an individual who...

FDA Commissioner Margaret Hamburg to Resign Next Month

14/02/2015 12:49
  Margaret Hamburg, one of the  longest-serving commissioners in US Food and Drug Administration (FDA)  history, plans to announce her resignation tomorrow, FDA officials have  confirmed to Regulatory Focus.  Hamburg's final day at the  agency will be in late March...

Concept paper on the revision of EU GMP Annex 1– manufacture of sterile medicinal products

14/02/2015 12:43
At the beginning of February 2015, the European Medicines Agency (EMA) published a Concept Paper on the revision of Annex 1. Annex 1 of the EU GMP Guide is the Guideline for Europe which describes the requirements on the manufacture of sterile dosage forms. The reasons given for the revision are...

Good manufacturing practice: data integrity definitions by MHRA

23/01/2015 22:37
Medicines and Healthcare products Regulatory Agency (MHRA) good manufacturing practice data integrity expectations for the pharmaceutical industry.Document:

ISO 9001: 2008 Quality Management Systems – Requirements

23/01/2015 20:58
ISO 9001:2008

USFDA 483s Published in 2014 by USFDA

23/01/2015 20:41
The ORA (Office ofRegulatory Affairs) ElectronicReading Room displays FDA 483's copies. USFDA is making these records publiclyavailable either (1) proactively at USFDA's discretion or (2) because they are"frequently requested" per the Electronic Freedom of Information ActAmendments of 1996. Some...

GMP Non-compliance reports (North China Pharmaceutical Group Semisyntech Co., Ltd, China) Published by EMA

23/01/2015 20:36
Non-compliance report of North China Pharmaceutical Group Semisyntech Co., Ltd by French National Agency for Medicines and Health Products Safety...

GMP Non-compliance reports (AGEPHA, Austria) Published by EMA

23/01/2015 20:32
The recent 'GMP non-compliance report' issued and published by...

USFDA Inspections/483s Dashboard

04/01/2015 01:07
FDAzilla's Inspections Database and 483 Listings have been merged as of November 2013.  Form 483s are issued out of inspections and raw numbers mean less when ratios tell a more important story.  Below is a bar chart of inspections by month; the height of the bar represents the number of...

USFDA Warning Letter to Novacyl Wuxi Pharmaceutical Co., Ltd. 12/19/14

04/01/2015 00:53
USFDA issued warning letter to Novacyl Wuxi Pharmaceutical Co., Ltd., an API & FinishedProduct manufacturer in China and let us assess our existing controls againstthese cGMP deviations/ violations.Summary of cGMP Violations:API: CGMP DEVIATION1.    Failure to...

Delegated Regulation on GMP for APIs published in the Official Journal of the EU

04/01/2015 00:16
Article 47 of Directive 2001/83/EC (Community code relating to medicinalproducts for human use) requires that the EU Commission enforces principles andguidelines of good manufacturing practice for medicinal products and APIs. Thelatter should be adopted in the form of a delegated act (wording of...

Elemental impurities: ICH Q3D has reached step 4 (final guideline)

04/01/2015 00:04
Elemental impurities (=heavy metals) play a key role in the update of the ICH Q3X series of regulations. ICH Q3D, which is aiming to control the level of metal impurities in medicinal products, has now reached step 4 (final guideline) after step 2b was entered in July 2013. The guideline consists...

Seetharam Kandarpa Receives ASQ Quality Auditor

03/01/2015 22:40
Milwaukee, Wis., 12/06/2014 - The Certification Board of ASQ (American Society for Quality) is pleased to announce that Seetharam Kandarpa has completed the requirements to be named an ASQ-Certified Quality Auditor, or ASQ CQA.As such, Seetharam Kandarpa has reached a significant level of...

Complimentary Life Sciences Guidebook: Best Practices for FDA Compliance software solutions

18/06/2014 23:26
Selecting, Implementing, and Using FDA Compliance Software Solutions:THE LIFE SCIENCES GUIDEBOOK This guidebook provides you with a basic overview for selecting, implementing and using FDA Compliance and Quality Management solutions. Learn the importance of QMS, best practices for FDA...

Class 2 Medicines Recall (action within 48 hours): Clarithromycin 500mg Powder for Solution for Infusion in Agila livery manufactured Strides Arcolab International Limited (EL (14)A/07)

18/06/2014 23:09
  Class 2 Medicines Recall (action within 48 hours): Clarithromycin 500mg Powder for Solution for Infusion in Agila livery manufactured Strides Arcolab International Limited (EL (14)A/07)   Source: MHRA

Fake Antibiotics Feed Growing Worldwide Superbugs Threat

18/06/2014 23:05
Antibiotics now rank among the most counterfeited medicines in the world, feeding a global epidemic of drug-resistant superbugs.   Read more  

Adverse drug reactions e-modules

18/06/2014 23:01
NHS Education for Scotland (NES) in conjunction with the Yellow Card Centre Scotland has launched six new e-learning modules to support healthcare professionals in identifying and reporting Adverse Drug Reactions (ADRs). Adverse Drug Reactions e-Modules (external link)   To access the...

Death by prescription painkiller

18/06/2014 22:36
The number of deaths involving commonly prescribed painkillers is higher than the number of deaths by overdose from heroin and cocaine combined, according to researchers at McGill University. In a first-of-its-kind review of existing research, the McGill team has put the spotlight on a major public...

Medical Device News: Microwave Helmet 'Can Spot a Stroke'

18/06/2014 22:15
Scientists say they have devised a helmet that can quickly determine whether a patient has had a stroke. It could speed diagnosis and treatment of stroke to boost chances of recovery, the scientists say. BBC  

India's Data Integrity Problems

18/06/2014 22:13
In recent months, the US Food and Drug Administration (FDA) has identified nearly a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities. Those data are intended to ensure that products meet pre-established specifications,...

Guidelines on requirements and expectations for the qualified person in a pharmaceutical company by DHMA

18/06/2014 21:33
The Danish Health and Medicines Authority (DHMA) has published a document which shows that the EU has left enough leeway for the implementation of EU directives. This could be an option in other EU Member States to prevent the threatening shortage of QPs (Qualified Persons).  EU Directive...

HMPC Q&A Documents on Herbal Medicinal Products

18/06/2014 21:30
EMA's HMPC (Committee on Herbal Medicinal Products) published the Questions & Answers document on (traditional) herbal medicinal products. The document also addresses herbal medicinal products which don't have a European tradition. The Q&A document contains Questions & Answers about the...

Regulators Again Find Data Integrity Problems at Indian Manufacturing Site

18/06/2014 21:20
  Regulators Again Find Data Integrity Problems at Indian Manufacturing SiteBy Alexander Gaffney, RAC 

Final QP Declaration Template by EMA

18/06/2014 15:43
More than three years ago, the EMA has published two draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its supply chain called "The QP declaration template": 1. The draft template for the Qualified Person's...

Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants by APIC

18/06/2014 00:45
An APIC multinational working group has compiled a new guidance on cleaning validation with the title "APIC Guidance on Aspects of Cleaning Validation in Active Pharmaceutical Ingredients Plants". Publication date is May 2014 and the document can be downloaded from the APIC website. The...

FDA launches openFDA to provide easy access to valuable FDA public data

15/06/2014 22:40
The U.S. Food and Drug Administration has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. In alignment with the recent Presidential Executive Order on Open Data...

Seetharam Kandarpa Receives ASQ-Certified Pharmaceutical GMP Professional

14/06/2014 07:48
  Milwaukee, Wis., 06/07/2014 — The Certification Board of ASQ is pleased to announce that Seetharam  Kandarpa has completed the requirements to be named an ASQ-Certified Pharmaceutical GMP  Professional, or ASQ-CPGP.   As such, Seetharam Kandarpa has reached a...

Important Judgement in the GMP World: EU Commission entitled to take far-reaching Decisions when GMP Deviations are found

12/06/2014 21:49
A judgement of the EU Court of Justice (Sixth Chamber) from 10 April 2014 on the suspension of the marketing and the withdrawal of certain medicinal products batches has been published. The judgement highlights the importance of the decisions taken by the EU Commission. Moreover it is pointed out...

Particles continue to cause major compliance problems and recalls

11/06/2014 22:04
Again, a batch of sterile products has been recalled due to detected particles. In this case, the company Hospira has initiated a recall of the medicinal product "Labetalol Hydrochloride". Labetalol Hydrochloride a clear colourless solution for intravenous administration used in cases of severe...

New Procedure for co-ordinating GCP-Inspections by CHMP

10/06/2014 22:06
The GCP Inspectors Working Group of the European Medicines Agency (EMA) has finally published the Procedure for coordinating GCP inspections requested by the CHMP (EMA/INS/GCP/55482/2013). This procedure describes the different steps of the Good Clinical Practice (GCP) inspection process and...

Health & drug to remain under administrative control of two ministries despite streamlining process by Modi govt

30/05/2014 11:40
Though the new government led by Narendra Modi in India has merged different departments and streamlined the ministries for better governance and control while reducing the flab, the control of the health and drugs will remain under two ministries, maintaining the status quo. Sources said though...

Mylan launches atovaquone & proguanil hydrochloride tablets

30/05/2014 11:37
  Mylan Inc., a global pharmaceutical company committed to setting new standards in health care, has launched atovaquone and proguanil hydrochloride tablets, 62.5 mg/25 mg and 250 mg/100 mg, the generic version of GlaxoSmithKline's Malarone tablets.  Mylan received final approval from...

FDA Warns German Drugmaker for Potentially Contaminating Products

28/05/2014 15:42
    German drugmaker Sanum-Kehlbeck has been cited for using the same equipment to produce penicillin and non-penicillin products, a situation that could lead to serious allergenic reactions in some patients. The non-penicillin products could be contaminated with penicillin, the FDA said...

FDA Issues Final Guidance on "Considerations When Transferring Clinical Investigation Oversight to Another IRB"

28/05/2014 15:38
    FDA has issued final guidance on “Considerations When Transferring Clinical Investigation Oversight to Another IRB.”  The guidance is now available on FDA’s...

Indian Government to spend Rs 3,000 crore to strengthen drug regulatory

22/05/2014 10:24
  The government will invest Rs 3,000 crore over the next three years in the pharma sector to strengthen the drug regulatory system in the country. "Strengthening the regulatory system is on our agenda. Indian regulators are aware that there is a gap in the regulatory system which needs to be...

Sun Pharma gets warning letter from USFDA

22/05/2014 10:03
    Click to Read the News   Warning Letter            

EMA Official Details Obstacles to Reaching Mutual Reliance on GMP Inspections

22/05/2014 09:50
European and U.S. regulators have made strides towards mutual recognition of quality inspections so that companies being inspected by one regulator would not have to face an inspection by the other, but setbacks still remain, a top European regulatory official said. The FDA and Europe have been...

US FDA Guidance for Industry: ANDAs: Stability Testing of Drug Substances and Products and FDA Questions and Answers

22/05/2014 09:26
The USFDA has published “Guidance for Industry, ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers” in May 2014.  This guidance contains questions and answers from public comments generated during the drafting of “Guidance for Industry, ANDAs: Stability...

PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP)

22/05/2014 09:21
The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which will enter into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide.   While the EU GDP Guide is legally binding in the EU/EEA, the PIC/S GDP Guide is a non-binding guidance document...

Draft on Process Validation by WHO

22/05/2014 09:02
  Draft Document: Dated April 2014 the WHO published a proposal for a revision of appendix 7 (non-sterile process validation) as a supplementary to the Guidelines on Good...