Should Equipment Status Identification Labels be retained with the Batch Record?

 

Should Equipment Status Identification Labels be retained with the Batch Record?

Keeping equipment status identification labels with the batch record provides additional confirmation during the review process. But is it required?

http://www.gmp-compliance.org/enews_05182_Should-Equipment-Status-Identification-Labels-be-retained-with-the-Batch-Record_15218,15179,15156,15355,Z-QAMPP_n.html

Keeping equipment status identification labels with the batch record or other files is often done to provide additional confirmation during review of the record. It supports verification that certain equipment was cleaned before usage for manufacturing. But is it required?

The U.S. Food and Drug Administration FDA has answered this question in an Q&A Document. Assuming each major piece of equipment has a unique “Cleaning and Use Log” that is adequately retained, these “quick reference” equipment labels can be discarded according the agency. FDA sees “no value in the retention of such labels in addition to the required equipment log or batch record documentation. The labels serve a valuable, temporary purpose of positively identifying the current status of equipment and the material under process. Any status label should be correct, legible, readily visible, and associated with the correct piece of equipment. The information on the temporary status label should correspond with the information recorded in the equipment cleaning and use log, or the previous batch record for non-dedicated equipment.”

However, as said before, it might be useful keeping these labels in a batch record. Many companies are doing so; not because it is a requirement but it is a helpful and reliable practice.

 

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Revised Ph. Eur. Chapter on Raman Spectroscopy introducing PAT

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The revised General Ph. Eur. Chapter on Raman Spectroscopy (2.2.48) comes into operation on April 1, 2016. The Chapter now includes hand-held devices and adaption to PAT purposes. Find out more about the revised  Ph. Eur. Raman Spectroscopy chapter.

http://www.gmp-compliance.org/enews_05181_Revised-Ph.-Eur.-Chapter-on-Raman-Spectroscopy-introducing-PAT_15153,15386,Z-PDM_n.html

The revision of the General Ph. Eur. Chapter on Raman Spectroscopy (2.2.48) comes into operation on April 1, 2016.

The revised Chapter has been published in Ph. Eur. Supplement 8.7. It has been completely rewritten to include now available handheld devices and adaption to Process Analytical Technology (PAT). Raman Spectroscopy has received more and more attention in pharmaceutical industry. Hand-held instruments are suitable for rapid identification purposes for example in the incoming goods control of raw and packaging materials.

Hand-held instruments require different tolerances for wavenumber scale verification than benchtop models. Therefore, an inter-laboratory study was organized and the results have been published in a corresponding paper titled “Rationale for the update of the European…

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Frequent Asked Question: Which Level of Ozone is Required in a Hot- or Cold-Stored WFI System?

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Ozone can be used for the sanitisation of water systems. Which level of concentration is required in water – i.e. in WFI – depends on different factors. Read more about the sanitisation of water systems with ozone.

http://www.gmp-compliance.org/enews_05131_Frequent-Asked-Question-Which-Level-of-Ozone-is-Required-in-a-Hot–or-Cold-Stored-WFI-System_15160,15154,15090,Z-PEM_n.html

The usage of ozone is only senseful in cold water systems. But the decisive question is whether ozone is used for a short-term (1-2 hours) or for a long term (> 6 hours) prevention of microbial growth. In the first case, > 50 ppb ozone is generally sufficient whereas in the second case at least 20 ppb are required.

One should keep in mind that WFI cold systems have basically a higher risk of microbial contamination. The need for ozone in large ring systems or in areas difficult to access may be higher. The ozone levels mentioned should thus be achieved in the return flow. Setting the correct ozone concentration for the…

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New Website ECA Validation Group: Version 02 of ECA´s Good Practice Guide on Validation online available

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The ECA Validation Group was founded in autumn 2011 by representatives of the pharmaceutical industry after ECA´s 4th European GMP Conference. The mission of the group is to assemble knowledge on Validation, for example by continuously developing ECA´s Process Validation Good Practice Guide. Now the Validation Group launched a new website.

Since the ECA Foundation was established back in 1999 its mission has been to provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances. For that purpose the ECA has initiated and established various working and interest groups concentrating on different topics.

The ECA Validation Group was founded in autumn 2011 by representatives of the pharmaceutical industry after ECA´s 4th European GMP Conference. This group’s mission is to assemble knowledge on Validation, for example by continuously developing ECA´s Process…

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When can a Chemical Substance be qualified as a “New Active Substance”? The New Reflection Paper of the EMA gives Information

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When can a Chemical Substance be qualified as a “New Active Substance”? The New Reflection Paper of the EMA gives Information

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 physiologically active molecule present for example in different salts or esters? In which cases do the different derivatives of an effective substance have the NAS status?

The EMA provides clarification to these questions in a new Reflection Paper which was published on 19 January this year. The document entitled  “Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances” describes the criteria according to which isomers, mixtures of…

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Mr. Glenn Saldanha Chairman & and Managing Director, Glenmark Pharmaceuticals Limited, conferred ‘India Pharma Leader Award’ by the Government of India

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Indian Ministry for Chemicals and Fertilizers on Thursday conferred 1st India Pharma awards to 12 Indian drug companies under various categories to motivate Indian Pharma and medical devices industries.

As per reports, Union Minister for Chemicals and Fertilizers Ananth Kumar conferred

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Frequent Asked Question: Which Level of Ozone is Required in a Hot- or Cold-Stored WFI System?

 

Ozone can be used for the sanitisation of water systems. Which level of concentration is required in water – i.e. in WFI – depends on different factors. Read more about the sanitisation of water systems with ozone.

http://www.gmp-compliance.org/enews_05131_Frequent-Asked-Question-Which-Level-of-Ozone-is-Required-in-a-Hot–or-Cold-Stored-WFI-System_15160,15154,15090,Z-PEM_n.html

The usage of ozone is only senseful in cold water systems. But the decisive question is whether ozone is used for a short-term (1-2 hours) or for a long term (> 6 hours) prevention of microbial growth. In the first case, > 50 ppb ozone is generally sufficient whereas in the second case at least 20 ppb are required.

One should keep in mind that WFI cold systems have basically a higher risk of microbial contamination. The need for ozone in large ring systems or in areas difficult to access may be higher. The ozone levels mentioned should thus be achieved in the return flow. Setting the correct ozone concentration for the system must be done within the scope of the PQ – i.e. validation of the water system.

In contrast, ozonisation of hot-stored WFI systems doesn’t make sense. Indeed, the half-life of ozone considerably decreases at temperatures over 40° Celsius. Moreover, the heat in hot WFI system causes sanitisation itself; the usage of additional ozone wouldn’t be meaningful. The risk of biofilm formation in hot-stored WFI systems is considerably lower.

 

 

 

 

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New Website ECA Validation Group: Version 02 of ECA´s Good Practice Guide on Validation online available

The ECA Validation Group was founded in autumn 2011 by representatives of the pharmaceutical industry after ECA´s 4th European GMP Conference. The mission of the group is to assemble knowledge on Validation, for example by continuously developing ECA´s Process Validation Good Practice Guide. Now the Validation Group launched a new website.

Since the ECA Foundation was established back in 1999 its mission has been to provide support to the Pharmaceutical Industry and Regulators to promote the move towards a harmonised set of GMP and regulatory guidelines by providing information and interpretation of new or updated guidances. For that purpose the ECA has initiated and established various working and interest groups concentrating on different topics.

The ECA Validation Group was founded in autumn 2011 by representatives of the pharmaceutical industry after ECA´s 4th European GMP Conference. This group’s mission is to assemble knowledge on Validation, for example by continuously developing ECA´s Process Validation Good Practice Guide.

Now the group launched its new website to provide members and those interested with information and practical tools. Here’s what you can find on the new website:

• Current News
• A news archive
• Training Courses and Validation Conferences
• ECA´s Process Validation Good Practice Guide
• Discussion Forum
• Presentations
• Useful links
• Q&A section
• Membership information

Members of the group have now the opportunity to download the version 2 of  ECA´s Good Practice Guide on Validation free of charge. On 174 pages the revised Good Practice Guide comprises the main elements of the new validation approach (“what to do”). On the other hand, it also serves as a supporting guide for the implementation (“how to do”).

To find out more we invite you to visit the ECA´s Validation Group new website.

 

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When can a Chemical Substance be qualified as a “New Active Substance”? The New Reflection Paper of the EMA gives Information

 

When can a Chemical Substance be qualified as a “New Active Substance”? The New Reflection Paper of the EMA gives Information

 

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 physiologically active molecule present for example in different salts or esters? In which cases do the different derivatives of an effective substance have the NAS status?

The EMA provides clarification to these questions in a new Reflection Paper which was published on 19 January this year. The document entitled  “Reflection paper on the chemical structure and properties criteria to be considered for the evaluation of new active substance (NAS) status of chemical substances” describes the criteria according to which isomers, mixtures of isomers, complexes, derivatives, esters, ethers, salts and other solid forms of  physiologically active molecules can be classified as “NAS “. If an applicant claims the NAS status of a substance to the regulatory authority in the centralised (CP) or decentralised procedure (MRP/DCP), the authority will first check whether the claim is justified. Afterwards – in case of a positive decision – the usual review of the application dossier will be performed.

http://www.gmp-compliance.org/enews_5189_When-can-a-Chemical-Substance-be-qualified-as-a-%22New-Active-Substance%22-The-New-Reflection-Paper-of-the-EMA-gives-Information_n.html

The applicant can refer to the criteria described in this Reflection Paper to substantiate his/ her claim of a NAS status. In general, the evidence has to be brought for the derivative in question that it differs significantly  in properties with regard to efficacy and /or safety from the already approved active substance.

The scope of this Reflection Papers covers neither biological and biotechnological active substances nor active substances to be included in radiopharmaceuticals.

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