GMP Environmental Control for Pharmaceutical Clean Rooms

The subject of clean room contamination due to personnel is discussed.

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Environmental control of pharmaceutical clean rooms is essential to the manufacture of a quality product. The definition of Environmental Control vs. Environmental Monitoring is discussed. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination.

Therefore, the design, validation and ongoing monitoring of a clean room HVAC system is necessary to assure the quality and safety of the pharmaceutical product. Also, a proper understanding and testing of the clean room environment according to international regulatory standards is important from a compliance perspective

It is important that a clean room’s HVAC system is fully understood, properly designed and properly validated. If this is accomplished, it will provide the environmental control necessary to meet the regulatory particulate and microorganism levels necessary to manufacture quality pharmaceutical product.

This webinar first details and explains the various US and international regulatory requirements for various clean room classifications. Next, the webinar provides a comprehensive overview of the mechanics of clean room HVAC. This includes engineering diagrams and schematics. HVAC equipment components are detailed as well as the automated control systems that are available. Clean room design considerations are included. Proper building construction and layout is necessary to achieve both optimum efficiency of the system and optimum cleaning and sanitization of the clean room.

The principles of HEPA filtration are described along with desired clean room airflow patterns and how to achieve them. Proper procedures for HEPA filter leak testing is included. The webinar then provides valuable information on differential pressure, air velocity , flow rates, and air pressure balancing. Temperature and relative humidity controls and specifications are also detailed.

Comprehensive procedures for cleaning and sanitization of the clean room environment are presented along with a review of the best disinfectants currently available along with their respective advantages and disadvantages. The subject of clean room contamination due to personnel is discussed. This includes both gowning technique and aseptic practices.

Finally, a full set of requirements for HVAC system validation is detailed. Ongoing monitoring of the clean room environment is discussed with respect to schedule, specifications and OOS (out-of-spec) actions that may be required.

  • Quality Assurance
  • Environmental Monitoring
  • Microbiology
  • Manufacturing
  • Validation
  • Engineering
  • Maintenance

Personnel Gowning and Aseptic Practices in Clean Room

Design Verification and CAPA Effectiveness Checks [Plans for Process] Validation

How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates.

This is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

  • How to link risk with the confidence statements associated with the sampling plans
  • Identify a variety of sampling plans, that all make the desired confidence statements
  • Select from among these sampling plans that plan which offers the best balance between the number of units tested and the risk of failing the validation
  • How to identify when sampling plans for other properties are required for things like precision, accuracy, homogeneity and failure rates

Approaches and sources of such plans are explained and contrasted with manufacturing sampling plans.
Ensure compliance when selecting sample sizes.
Learn strategies for reducing sample sizes.
Learn strategies for avoiding false rejections.

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  • Claims that can be made when passing a sampling plan
  • How to select a sampling plan to make a specific claim
  • Different types of sampling plans including single, double and variables
  • How to reduce the number of units tested
  • How to increase the chances of a good product/process passing a validation
  • How to write protocols to handle contingencies so to avoid deviations
  • Practical considerations including selecting representative samples

Sampling Plan Analyzer and Distribution Analyzer software packages as well as providing consulting and training on Statistics including Robust Design, Tolerance Analysis, Design of Experiments, Trending and Acceptance Sampling.

QbD Development Process Evaluating Critical Steps

The selection of robust process parameters for Quality designs, and how to establish criteria to measure and discernable observances.

  • How to Build quality, safety, and efficacy into the manufacture of drug product
  • The ICH guidelines for pharmaceutical manufacturing
  • Risk-based, modern pharmaceutical manufacturing
  • Understanding Target Quality Profile, Critical Quality Attributes
  • Process parameters and design experiments
  • Regulatory concerns FDA and EMA on QbD

To establish a procedure for the proper assessment of product and process design, Also, to align evaluation of product quality standards for chemistry manufacturing and controls (CMC) review and to maintain quality standards per Office of Pharmaceutical Science (OPS)

It should be noted that OPS is responsible for assuring that the quality of drug products for the entire pharmaceutical industry follow uniform policy and review processes during drug product development (the manufacture and formulation).

Therefore, it is incumbent on all personnel involved with the preparation of documentation for subsequent submission to the regulatory authority recognize the importance of creating and maintaining a clear scientific and sound approach for all products.

  • Quality target product profile (QTPP) forms the basis for design and the development of the product. Considerations for the Quality Target Product Profile (ICH guideline Q8 R2)
  • Critical quality attributes (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality
  • Process Analytical Technology (PAT) which is a Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
  • Risk Assessment (RA)one can recognizing critical attributes that are going to affect final quality of product

Process Evaluating Critical Steps

Webinar from Compliance4All on January 9, 2019 on Supervising a Human Error Free Environment

The tools that the speaker will offer at this course can be used for implementation immediately.

Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 9, 2019. The topic of the webinar is “Supervising a Human Error Free Environment: You can do a Lot More than you Think”, and the speaker is Ginette Collazo, an Industrial-Organizational Psychologist.

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502284LIVE

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In many industries, despite the many advances that have shaped safety standards, human error is still a factor to be reckoned with seriously. Human error, despite taking what one thinks are the best precautions, can lead to loss of quality, processes and production, not to mention the financial one.

What is needed is a comprehensive approach to elimination of human error. While it is acknowledged that human error can never be eliminated, one can take care from many angles and perspectives to minimize it. This should start at the design stage. Good Manufacturing Practices (GMP) regulations need to be implemented in complete faith. The approach should be to identify the root of the human error first and then take the necessary steps to address them.

These should be done in complete sync and harmony with the concerned staff members in charge of safety and in accordance with the principles of GMP. The specific methodologies needed for implementing these will be the essence of the learning this 90-minute webinar will impart.

The speaker will explain strategies with which the unit can use a specific methodology with which to sync and approach issues in GMP related environments that uses a method for correcting, preventing and avoiding recurrence of these issues. She will also describe the practical approaches that can be adhered to while supervising on the floor.

She will also drive home the importance of supervision in reducing and preventing human error and show ways by which to implement metrics that can help track and measure human error rates. The five elements of ensuring a human error-free environment will be discussed at this webinar. The tools that the speaker will offer at this course can be used for implementation immediately.

This webinar will serve the following learning objectives:

  • Understand human error: factors and causes
  • Understand the importance of supervision in creating a high reliable group for both regulatory and business compliance
  • Discuss issues related to supervision and how to avoid traps that will allow errors to occur
  • Identify Root Causes and CAPA associated to supervision.
  • Learn how to measure human error rates at your department and keep track of metrics
  • Identify what I can do to support human reliability at the site.

This course will be beneficial to Supervisors, Managers and Directors, Operations, Manufacturing, Plant Engineering, QA/QC Staff, Process Excellence/Improvement Professionals, Industrial/Process Engineers, Compliance Officers, Regulatory/Legislative Affairs Professionals, and General/Corporate Counsel.

About the speaker:

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.

Facts About Compliance Courses

What is compliance? We all know the commonly used meaning of the term. One of the meanings The Oxford Online Dictionary has for compliance is its being “(t) he state or fact of according with or meeting rules or standards”. So, in the context of the regulated industries, compliance is being in a state of acquiescence or agreement with the regulatory requirements. The rules or requirements are set out by the regulatory authorities such as the US FDA or the European Union’s European Medicines Agency (EMA), or The Medicines and Healthcare Products Regulatory Agency (MHRA) of the UK, or The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, or any other around the world.

The regulations these regulatory agencies set are aimed at ensuring compliance with standards. Of course, it goes without saying that these standards are aimed at ensuring quality and safety of drugs and other health-related products such as medical devices, food, medicines, life sciences and pharmaceutical products. It is to be in compliance with the regulations set out by these agencies that organizations that come under these regulatory bodies spend a fortune.

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Why? Simple:

– Being in compliance ensures that their products are approved for release into the market, failing which all that they spend on producing the product goes down the drain;

– Lack of compliance results not only in hefty penalties and fines and other punishments which could go all the way to imprisonment; it could also result in earning a bad reputation, the quickest means to get out of business.

Compliance requirements, expectedly, are very stringent. This is very natural, considering the nature of the products that are regulated. No regulatory agency likes to take chances with the health of the people. One spurious drug in a lot of thousands could be enough to cause damage to the consumer. So, regulating these products is as onerous as ensuring the security of every individual in a nation or society.

Compliance requirements are couched in very formal and often incomprehensible language. Since the industries are highly specialized, it is impossible for the regulatory agencies to avoid jargon or legalese. It is to help understand the nuances of these regulations that organizations need the services of compliance professionals. These professionals are specialized in the particular and exact nature of these regulations and do what is required to ensure compliance.

Despite the existence of these compliance officers, many organizations could still need understanding of the regulations. This could sometimes be because of the frequency of the regulatory updates or the urgency in meeting their requirements. Or, these could be beyond the resources the organization can allocate or afford for meeting compliance requirements. Further, the nature of some regulations could be such that even experienced compliance officers may need clarity. On such occasions, organizations need the services of compliance trainings.

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How to Effectively Manage CROs/Vendors used in the [Pharmaceutical Industry]

It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

Today’s globalized and interconnected world has made outsourcing indispensable. Outsourcing works to the benefit of both parties. Those who outsource can let other, independent companies, usually those that have specialized in this function, to take over several of their secondary processes, so that they can concentrate on the more productive and business-yielding activities. At the other end, the outsourced company earns substantial revenues by carrying out outsourced activities.

In the pharmaceutical industry, it is necessary and important to employ efficient and accurate strategies for this important activity. When projects are outsourced without proper safeguards and monitoring going into them, the outsourcing company has higher chances of inviting FDA actions such as Warning Letters, 483’s, etc.

Putting a selection process in place is very important

Companies should put in place robust structures that help them select vendors successfully and avoid scenarios such as these. These systems should also ensure that other critical aspects of outsourcing activities in GXP areas such as contract design, quality monitoring and risk minimization remain compliant. It is imperative for pharmaceutical companies that outsource to get a thorough understanding of the elements of a sound outsourcing system.

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Complete learning on how to select CROs/Vendors

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will educate participants on the elements of managing and avoiding common pitfalls with CROs/Vendors.

Laura Brown, an independent Pharmaceutical Project Management and Training Consultant and is Course Director for the M. Sc. in Clinical Research at University of Cardiff’s School of Pharmacy; will be the speaker at this course.

Dr. Brown has over 20 years’ experience of managing clinical research projects in the pharmaceutical industry. She has worked in Project Management for several companies including Wellcome, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. She is also co-author of two books on Project Management, including Pharmaceutical Project Management, a 2004 publication.

Please enroll for this webinar by visiting http://bit.ly/2JJHZVz

Learning on all elements of CROs/vendor outsourcing

At this webinar, Dr. Brown will combine theory and practical examples to offer a crucial overview of a sponsor’s responsibilities, which will give them the knowledge needed to ensure quality oversight.

In the course of this session, Dr. Brown will cover the following areas:

  • Understand how to Effectively Manage CROs/Vendors used in the Pharmaceutical Industry
  • Build an Understanding of your Responsibilities as the Sponsor or the Vendor: Identifying the Right Level of Management and Oversight
  • Discover Tools and Processes to Manage CROs/other Vendors
  • Gain an insight for CROs/other Vendors of what Sponsors Expect and how to Meet their Expectations
  • Measuring CRO Performance including Metrics and Key Performance Indicators
  • Managing and avoiding common pitfalls with CROs/Vendors.

Personnel who work in areas that involve one or more aspects of outsourcing CRO’s/vendors, such as Vendor Management, Global QA/Compliance, Contracts and Outsourcing, VPs, Directors, Outsourcing Department Staff, Purchasing, Finance and Contract, Management Staff, Managers and other personnel involved in selecting and managing cross, will benefit from this course.

Dr. Brown’s webinar is also aimed at helping personnel involved in vendor/CRO/CMO oversight (including those working in Clinical Research, Regulatory Affairs Pharmacovigilance, and Manufacturing) in the pharmaceutical, biotechnology, medical device and biologic industries who use Contract Research Organizations (CROs/CMO).

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