The draft guidelines outlined in process validation: terminal sterilisation processes pharmaceutical products (GUI – 0074) applied to the validation of sterilisation of raw materials, packaging materials, and finished products pharmaceutical and veterinary drugs.
This guidance is to ensure that companies remain within compliance of good manufacturing practice (GMP)
More information is published on the health Canada website
Posted in manufacturing
Tagged letting, packaging, pharmaceuticals, Process validation, sterilisation
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Human plasma contains many proteins which, following extraction, purification, and formulation into medicinal products are of great medical importance. Plasma-derived products provide life-saving therapies but the quantity of plasma for fractionation is limited by the number of donors. Therefore, the exchange of intermediates between manufacturers or the use of a variant manufacturing process (see below) may be possible to assure the best use of blood/plasma donations.
Although the therapeutic use of blood transfusion goes back to the beginning of the 20th century, it was not until the 1940s that the technique of plasma fractionation, devised by Cohn and colleagues, enabled the widespread use of medicinal products extracted from human plasma.
Improvements in protein purification and molecular separation technology have made available a wide variety of products, with medical applications covering a large field, and the therapeutic value of these is unquestioned. However, the potential for viral transmission is well recognised, and because of the large number of donations which are pooled, a single contaminated batch of a plasma-derived product, with the contamination possibly originating from a single donation, can transmit viral disease to a large number of recipients. The recognition in the mid-1980′s that plasma-derived medicinal products, in particular coagulation factor concentrates, had caused widespread transmission of human immunodeficiency virus (HIV) and hepatitis C (previously identified as non-A non-B hepatitis) resulted in major changes to the manufacturing processes, with the introduction of specific steps to inactivate or remove these and other blood-borne viruses. Infectious non-enveloped viruses were detected in certain plasma-derived medicinal products during the 1990’s and early 2000’s. Therefore, recent process development has been devoted to further reducing non-enveloped viruses such as hepatitis A (HAV) and parvovirus B19 (B19V).
Measures taken to prevent infection include selection of donors, screening of individual donations and plasma pools for markers of infection with known viruses and validation of the production process for inactivation or removal of viruses. From the 1990’s on, measures designed to minimise contamination of the starting plasma have been improved by the refinement of serological test kits and the use of nucleic acid amplification technology (NAT) for the testing of viral DNA and RNA, thereby shortening the window period during which infectious donations are not detected.
Recent cases of apparent iatrogenic variant Creutzfeldt-Jakob disease (vCJD) infection by blood transfusion in man in the UK provide strong evidence that vCJD is transmissible through blood transfusion. Precautionary measures to minimize the risk of transmission of infectivity by plasma-derived medicinal products were put in place by CHMP in 1998 following the identification of the first cases of vCJD and have been kept under review and updated as needed.
The legal basis for EU minimum standards for the quality and safety of the starting material for plasma-derived medicinal products has been established along with the pharmaceutical legislation and specific provisions have been laid down in the pharmaceutical Directive 2001/83/EC as amended. In this legislation the option of a centralised certification of Plasma Master File was established.
In 2003 the European Parliament and the Council have adopted the overarching Directive 2002/98/EC “Setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components…”, also known as the “Blood Directive”. Thereby, from 8 February 2005, Directive 2002/98/EC amending Directive 2001/83/EC establishes the requirements for the collection and testing of human blood and blood components whatever the intended purpose. In line with this Directive, the technical Directives 2004/33/EC, 2005/61/EC and 2005/62/EC have been issued by the Commission. Guidance is also provided by the “Guide to the Preparation, Use and Quality Assurance of Blood Components” of the Council of Europe which contains a compendium of measures designed to ensure the safety, efficacy and quality of blood components.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
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This concept paper addresses the need to develop guidance on process validation of biotechnology derived active substances.
Guidelines related to the quality of Biotechnological/Biological products have been developed at the EU level, and several documents have been harmonised through the ICH process. However, these documents do not satisfactorily address the specific aspects of validation and evaluation for biotechnology derived products.
Validation and evaluation are essential concepts when setting the manufacturing process steps of biotechnology derived products. The evaluation/validation data provide essential information on the reproducibility and robustness of the process steps and are an important element to guarantee consistency in the quality of the product. The data encompass studies that are performed on product and process steps representative of the commercial process and may cover a wide range of situations and experiments (e.g. full scale, pilot scale, laboratory scale, scaled-down), depending on the objectives of the evaluation/validation studies carried out during development (e.g. consistency, viral safety evaluation, process-related impurity clearance).
The currently approved guidelines address the control of Biotechnological/Biological products (i.e. ICH Q6B on specification and ICH Q5C on stability), and/or some specific issues or aspects of the process (i.e. ICH Q5A on viral safety, ICH Q5B on genetic stability, ICH Q5D on cell substrates and ICH Q5E on comparability). ICH Q11, currently under development, is aimed at addressing the description, development, control strategy and process evaluation/validation of active substances of biotechnological and chemical origins. Although ICH Q5 and ICH Q11 documents address several important aspects or concepts relating to the evaluation/validation for medicinal products containing biotechnology derived proteins as active substance, as illustrated above there is no guidance to cover other aspects such as process- and product-related impurity clearance (e.g. host cell proteins, DNA), column/membrane sanitization and life time, hold time, reprocessing, pooling of intermediates and selection of batches to be included in evaluation/validation studies. All these elements do contribute to a good understanding of the process and the resulting product, and are needed for the assessors at the time of evaluation of a marketing authorisation application.
It is well acknowledged that ICH Q8, Q9 and Q10 guidelines are progressively being implemented in the routine practice of manufacturers and marketing authorisation holders. However, whereas these guidelines provide a new approach on the management of quality and build up the quality at every step of the life cycle of a medicinal product, they do not provide practical recommendations on the necessary evaluation/validation studies to be filed on these specific aspects (new application or variations).
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Posted in biotechnology, manufacturing
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This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.2 Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.
The lifecycle concept links product and process development, qualification of the commercial manufacturing process,3 and maintenance of the process in a state of control during routine commercial production. This guidance supports process improvement and innovation through sound science.
This guidance covers the following categories of drugs:
• Human drugs
• Veterinary drugs
• Biological and biotechnology products
• Finished products and active pharmaceutical ingredients (APIs or drug substances)4
• The drug constituent of a combination (drug and medical device) product
This guidance does not cover the following types of products:
• Type A medicated articles and medicated feed
• Medical devices5
• Dietary supplements
• Human tissues intended for transplantation regulated under section 361 of the Public Health Service Act6
This guidance does not specify what information should be included as part of a regulatory submission. Interested persons can refer to the appropriate guidance or contact the appropriate Center in determining the type of information to include in a submission.
This guidance also does not specifically discuss the validation of automated process control systems (i.e., computer hardware and software interfaces), which are commonly integrated into modern drug manufacturing equipment. This guidance is relevant, however, to the validation of processes that include automated equipment in processing.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Full Text Here
This guidance outlines the general principles and approaches that FDA considers appropriate elements of process validation for the manufacture of human and animal drug and biological products, including active pharmaceutical ingredients (APIs or drug substances), collectively referred to in this guidance as drugs or products. This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
This guidance aligns process validation activities with a product lifecycle concept and with existing FDA guidance, including the FDA/International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.2 Although this guidance does not repeat the concepts and principles explained in those guidances, FDA encourages the use of modern pharmaceutical development concepts, quality risk management, and quality systems at all stages of the manufacturing process lifecycle.
The lifecycle concept links product and process development, qualification of the commercial manufacturing process,3 and maintenance of the process in a state of control during routine commercial production. This guidance supports process improvement and innovation through sound science.
This guidance covers the following categories of drugs:
• Human drugs
• Veterinary drugs
• Biological and biotechnology products
• Finished products and active pharmaceutical ingredients (APIs or drug substances)4
• The drug constituent of a combination (drug and medical device) product
This guidance does not cover the following types of products:
• Type A medicated articles and medicated feed
• Medical devices5
• Dietary supplements
• Human tissues intended for transplantation regulated under section 361 of the Public Health Service Act6
This guidance does not specify what information should be included as part of a regulatory submission. Interested persons can refer to the appropriate guidance or contact the appropriate Center in determining the type of information to include in a submission.
This guidance also does not specifically discuss the validation of automated process control systems (i.e., computer hardware and software interfaces), which are commonly integrated into modern drug manufacturing equipment. This guidance is relevant, however, to the validation of processes that include automated equipment in processing.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
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This concept paper addresses the need to update the guideline on Process Validation. This guideline was originally adopted in February 2001. With the development of new ICH guidelines Q82, Q93 and Q104, this guideline is being reviewed in order to implement the concepts highlighted in the ICH guidelines.
The current guideline does not reflect the recent regulatory developments on Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing (RTRT).
The current guideline was developed before the elaboration of the new ICH guidelines Q8 Pharmaceutical Development, Q9 Risk Management and Q10 Quality Systems. With these new guidelines, additional opportunities are available to verify the control of the process by alternative means to the manufacture of traditional process validation batches. The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria. ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy. ICH Q8 refers to an ‘enhanced’ approach to pharmaceutical development which includes an alternative to the traditional process validation. Continuous process verification [see definition in ICH Q8(R2) glossary] can be utilised in process validation protocols for the initial commercial production and for manufacturing process changes for the continual improvement throughout the remainder of the product lifecycle. In contrast, the current note for guidance on process validation refers only to the more traditional approach of the manufacture of a number of validation batches to confirm that the process is under control. A revision to the note for guidance on process validation will bring it in line with ICH Q8, Q9 and Q10 documents and add the ‘enhanced’ approach to the current ‘traditional’ approach. The annexes of the current guideline will be included in the revised guideline. The revised guideline will also clarify to what extent ICH Q8, Q9 and Q10 should be followed when an applicant wishes to use alternative methods of process validation including continuous verification. The FDA guidance on process validation has been recently revised to take into account ICH Q8, Q9 and Q10. The revision to the note for guidance on process validation will provide a more harmonised approach.
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Posted in manufacturing
Tagged ICH Q10, ICH Q8, ICH Q9, manufacturing, Process validation
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