Four New Free Features to ACE Software Customers

Four New Free Features to ACE Software Customers

POMONA, CA (AUGUST 31, 2022) PSC Software® is excited to provide our ACE® electronic Quality Management System (eQMS) customers with four powerful enhancements. Current ACE users never have to pay for new features. These new features and modules widen user access to cutting-edge developments in the software at no extra charge, so users stay at the forefront of innovation in the life science industry. 

 

ACE®, PSC Software’s flagship product, is a highly configurable enterprise quality management system built to solve your company’s unique quality needs. With ACE you can streamline regulatory inspections to instantly respond to inspector requests, manage the entire audit life cycle, and reduce time spent on quality management.  

“ACE’s new features will help our customers achieve a host of quality assurance goals by reducing their burden and maximizing productivity. This is our most powerful upgrade to date. Each feature has been built to solve real-world pain points our customers face, creating easy-to-use solutions enabling customers to timely implement these cost effective and easy to use solutions.”

Brandon Clough

Chief Revenue Officer, PSC Biotech

In the latest ACE® software update, existing users will automatically have access to four new features:  

 

ACE Validation: Revolutionary paperless validation increases efficiency and reduces costs compared to traditional paper-based validation. Real-time collaboration, execution, and approval all in one system for all commissioning, qualification, and validation processes.  

ACE Risk: Build a robust risk matrix to identify potential failure and non-compliance issues before they occur. ACE Risk supports FMEAs and CCP determination throughout your Facility, Equipment, Utilities, Supply Chain, Vendors, Product Processes, Method, Safety, and beyond. 

ACE Supervision: ACE® pairs with wearable technology to provide hands-free, wearable technology to completely transform work in cleanrooms, maintenance shops, laboratories, and more. Capabilities include speech-to-text, video and audio recording, QR code scanning, and so much more.  

ACE Accelerator: Flexible configuration of workflows and functionality to meet your company’s changing needs as you grow. With 24/7 admin on-demand support and pre-validated workflows, this integrated solution will help accelerate your success at every stage.  

To access this new feature set, contact PSC Software® at sales@pscsoftware.com to schedule your free update. 

For more information about ACE®, the robust set of features ACE offers, or to schedule a demo, visit: https://biotech.com/2022/08/29/ace-new-releases/ 

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Structure of the Common Technical Document (CTD)- M4 Guideline

Structure of the Common Technical Document (CTD)- M4 Guideline

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Structure of the Common Technical Document (CTD)- M4 Guideline

Structure of the Common Technical Document (CTD)- M4 Guideline

What is the Common Technical Document (CTD)?

The Common Technical Document (CTD) format or dossier was designed by the ICH and was agreed upon as a common format between three major regulatory regions, i.e.  European Union (EU), USA, and Japan for submission of technical documentation included in an application for the registration of a human pharmaceutical product.

Background and Objective:

A marketing application submission typically requires a huge amount of information. Generally, comparable scientific and clinical information is required to be submitted in countries where the manufacturer or sponsor plans to market the drug.  Historically, submissions were in the paper format, which would need huge sponsor and agency resources as well as signifigant storage space. Most regions also had their own set of guidelines and format for submission of a regulatory dossier to obtain marketing approval for a new drug or a variation to an existing license. For example, in Japan, the GAIYO format was required. In the US, the Food and Drug Administration (US-FDA) had guidance documents regarding the format and contents of a New Drug Application (NDA). In Europe, Expert Reports and Summaries were required, additionally, countries within EU had their own guidelines and formats, which made the process more time-consuming and repetitive.

The CTD format was mainly implemented as a way to harmonize the content of the submission required for each of these major regions, this effort would greatly reduce the time and resources needed to compile applications for pharmaceutical products, as also making the whole submission process much more efficient in terms of global applications. The CTD indicates the content and organization of technical data when submitted to an Agency for their marketing approval.

Engineers

Overview of Electronic CTD or eCTD submissions:

USFDA had been accepting paper CTD application only until 2003, making the electronic submission or electronic CTD (eCTD) mandatory from May 2017. Most E-submission requirements have been phased in the recent years, including the New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) submissions, Drug Master Files (DMFs), Investigational New Drug application (IND) and Biologics License Applications (BLAs).

With an eCTD, each document is separate (granular) and named as per ICH specifications. Each submission has its own eCTD XML backbone file, which allows the FDA to receive, archive and review the submission smoothly.

Currently, apart from US, EU and Japan, most regulatory agencies around the world such as HAS (Singapore), Health Canada (Canada), MFDS (Republic of Korea), NMPA (China), Swissmedic (Switzerland) have already implemented and highly recommend electronic submissions or eCTD format for most regulatory submissions.

Refer to the ICH M8 guideline on Electronic Common Technical Document (eCTD), for additional details on the eCTD and implementation status of the eCTD in major countries.

 

Organization of the Common Technical Document:

The general principle that is followed for any CTD document is that the information within the application must be unambiguous and transparent, in order to ensure efficient review of the data. Refer to the M4_R4 guideline (Source: https://database.ich.org/sites/default/files/M4_R4__Guideline.pdf) for more detailed formatting principles to be followed for the CTD document.

 

The Common Technical Document (CTD) dossier is organized into 5 Modules:

Module 1: Administrative Information and Prescribing Information

Module 1 contains documents specific to a region, example, application forms, and proposed label for use in the region. This Module is mostly specific for each region, and is thus, not harmonized as the other Modules.

Module 2: Common Technical Document Summaries

Module 2 typically consists of 7 sections as outlined below and contains summaries of Quality, Non-clinical and Clinical data that are provided in Module 3, Module 4, and Module 5 respectively.

  • CTD Table of Contents
  • CTD Introduction
  • Quality Overall Summary
  • Nonclinical Overview
  • Clinical Overview
  • Nonclinical Written and tabulated Summaries
  • Clinical Summary

Module 3: Quality

Module 3 presents the chemistry, manufacturing, and controls reports for the product presented in the dossier. This Module gives complete detail of the manufacturing of the Active pharmaceutical ingredient or the drug substance and the drug product such as manufacturer details, product development, manufacturing steps, critical process parameters and in process controls as well as details related stability of the product, drug substance, raw materials and other excipients and analytical validation process as relevant to the product.

The main headings of this Module are as below:

3.1 Table of Contents for Module 3

3.2. Body of Data

3.2.S Drug Substance

3.2.P Drug Product

3.3. Literature references used in Module 3

Module 4: Non-clinical Study reports/ Safety

 Module 4 also known as the Safety Module, consists of all the study reports and assessments indicating safety of the product. The data in this module pertains to non-clinical or pre-clinical studies conducted for the drug product. This Module typically includes studies related to Pharmacology, Pharmacokinetics, Pharmacodynamics, Toxicology as relevant to the drug product.

The main sections of this Module are as below:

4.1 Table of Contents for Module 4

4.2. Study reports

4.2.1. Pharmacology

4.2.2. Pharmacokinetics

4.2.3. Toxicology

4.3. Literature references used in Module 4

Module 5: Clinical Study Reports/ Efficacy

Module 5, also known as the Efficacy module, indicates all the study reports and assessments that prove that the product shows efficacy for the target indication. This Module is the most extensive, the length of which depends on the number of clinical studies conducted (Phase 1, Phase 2, and Phase 3 study data). The data within this Module pertains to complete details of clinical study reports, cross-study analyses, post-marketing data, clinical pharmacology, biopharmaceutic studies, clinical efficacy, and clinical safety as relevant to the product.

Refer to the ICH CTD page, for additional details on the content and format of each Module outlined above.

 Today, as the CTD format is widely used and accepted, sponsors have been able to use one common format to submit their marketing applications to major markets across the world. Thus, as a company, if you are dealing with a pharmaceutical product or a biological product, you will most certainly use the CTD format for most of the applications.

PSC Biotech® Regulatory Experience

PSC Biotech® has in-house regulatory expertise and offers expert guidance and support with respect to managing your global regulatory submissions and drafting the eCTD Modules (Module 1 to Module 5) as well as navigating all the regulations pertaining to your product. Apart from the generation of eCTD Modules, PSC also offers regulatory services in terms of drafting a regulatory framework and strategy as well as formatting and publishing of the eCTD Modules. Contact PSC Biotech to manage your submissions efficiently!

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Top 2 FDA Citations to Avoid

Top 2 FDA Citations to Avoid

The consequences of FDA citations can be costly. In this blog article, we discuss the top two FDA citations for pharmaceuticals and how to avoid or prevent them. In the United States of America, pharmaceutical drugs and medical devices are controlled according to The Code of Federal Regulations, Title 21: Food and Drugs (21 CFR). The FDA publicly releases warning letters and citations. Therefore, the cost of addressing citations and warning letters is not limited to production, maintenance, upgrades, or supply chain but also public confidence in your product and company.

Responsibilities of the Quality Control Unit

The Quality Control Unit (QCU) of a company may be referred to as the Quality Assurance Department or a similar name. This division of a pharmaceutical company is responsible for the ultimate quality of the product. The 21 CFR part 211.22, subpart B, details the responsibilities of the quality control unit.

Applying Quality Risk Management (QRM) to C&Q Planning

§ 211.22 Responsibilities of the quality control unit.

(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated. The quality control unit shall be responsible for approving or rejecting drug products manufactured, processed, packed, or held under contract by another company.

(b) Adequate laboratory facilities for the testing and approval (or rejection) of components, drug product containers, closures, packaging materials, in-process materials, and drug products shall be available to the quality control unit.

(c) The quality control unit shall have the responsibility for approving or rejecting all procedures or specifications impacting on the identity, strength, quality, and purity of the drug product.

(d) The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.

– Code of Federal Regulations Title 21 Section 211.22

The most frequent FDA citation in pharmaceuticals is 21 CFR part 221.22, subpart B, letter D: “The responsibilities and procedures applicable to the quality control unit shall be in writing; such written procedures shall be followed.” CFR §211.22(d) accounts for 27% of the observations recorded from 2016 to 2020. This part of the code seems logical, simple, and should be easy to follow. So, why is it the most cited part of the code? Obviously, the procedures are not entirely in writing or wholly followed.

Therefore, having the quality control procedure and the product review documented appropriately is absolutely critical to avoid this citation. We will discuss the second most cited part of 21 CFR before discussing ways to avoid or prevent both citations.

Production Record Review

The next most common citation is regarding production record review, precisely 21 CFR part 211, subpart J, 192. CFR §211.192 accounts for 31% of the observations made by the FDA from 2016 to 2020.

Reviewing documents 101

§ 211.192 Production record review.

All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.

– Code of Federal Regulations Title 21 Section 211.22

Examples of frequent observations for CFR §211.192:

    • There is a failure to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed.
    • Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
    • No written record of investigation
    • The written record of the investigation is incomplete.
    • Quality control unit review of records – Drug product production and control records are not reviewed by the quality control unit to determine compliance with all established and approved written procedures before a batch is released or distributed.

Actions to avoid, prevent or reduce similar observations

a) Create and Implement Quality Systems
b) Create a QCU and establish adequate policies and procedures
c) Follow the six-system inspection model approach for a self-inspection program
d) Monitor the regulatory compliance activities through regular management reviews

a) Create and Implement Quality Systems
    • Quality – product quality
    • Quality by Design – pre-development, development, and launch
    • Quality Risk Management –
    • Corrective And Preventive Action (CAPA)
    • Change Control
    • Quality Unit
    • Six-system based inspection model (quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling.
b) Create a QCU and establish adequate policies and procedures
    • Procedures need to be clear and describe the responsibilities and authority of the QCU for:
      • approving regulatory and controlled documents,
      • approving or rejecting all components, drug products containers and closures, in-process materials, packaging materials, labeling, and drug products, including those manufactured, processed, packed, or held under control by another company
      • Reviewing batch records to ensure compliance with the requirements etc.
c) Follow the six-system inspection model approach for a self-inspection program
    • Quality, production, facilities and equipment, laboratory controls, materials, and packaging and labeling

Six-System Inspection Model is described according to four major factors:

i) Management responsibilities

ii) Resources

iii) Manufacturing operations

iv) Evaluation of activities

d) Monitor the regulatory compliance activities through regular management reviews on the following examples of Key Performance Indicators
    • Non-conformance and CAPAs
    • Customer Complaints
    • Field Alert Reports (FAR) and Medical Device Reporting under part 803
    • Recalls
    • Internal Audits
    • Training including GMP refresher training 

Summary

To prevent the top two FDA citations, 21 CFR §221.22 and §211.192, create and implement quality systems overseen by a QCU with written policies and procedures, and perform internal inspections and regular reviews. PSC Biotech® has quality professionals to help you evaluate gaps and conduct internal audits and inspections. Contact us today for a free consultation and quote to fit your budget and needs!

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With the ever-changing mechanics of innovation in the manufacturing environment, work from home and federal regulation validation strategies need to evolve to accommodate the new space. This white paper provides the background, rationale, and strategy for innovating validation for cell and gene therapy manufacturing. We focus on adapting to the unique challenges that advanced cell and gene therapy manufacturing encounters. How do you overcome supply chain, cost, volume, and speed and sensitivity issues specific to advanced cell and gene therapy products? Read this whitepaper for the latest in innovative strategies.

Table of Contents

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    • The Concept
    • Issues in Cell and Gene Therapy Manufacturing
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PSC® can assist in bringing your new cell or gene therapy to clinic

PSC Software®

PSC Software® provides innovative technology options for validation data and team communication for regulatory compliance. PSC Software® provides industry-leading real-time quality management software to ensure regulatory compliance goals are met while reducing business costs. See PSCSoftware.com for more information on our adaptive compliance engine (ACE®) products and inspection management system, AUDITUTOPIA®.

PSC Biotech®

PSC Biotech® consultants act as a seamless extension of your company to assist you in accomplishing the projects required to produce the highest quality products. See Biotech.com for more information about the services that we provide. PSC Biotech® has served life science companies in 52 countries across the globe. Contact us for a free consultation on tailored and cost-efficient project assistance for all your quality, validation, systems, and regulatory needs!

We look forward to hearing about your needs in Cell and Gene Therapies and whether we can be of service. Please get started by emailing us at info@biotech.com or using our contact form online. We have options for professional services and software across a range of budgets and constraints.

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Lean project management strategies incorporate subject matter experts (SMEs) in cross-functional teams. For example, commissioning equipment with computerized functions needs to be validated by the computer systems validation SME and the commissioning and qualification validation SME. This white paper discusses some considerations for using a multi-disciplinary team approach to sitewide or corporate Validation project planning, oversight, execution, and approval.

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Multi-disciplinary teams for GxP

The establishment and management of multi-disciplinary validation teams are crucial to managing changes in the modern Pharmaceutical and Biopharmaceutical industries. These teams are typically responsible for the review, planning, and approval of changes (additions of or modifications) to equipment, facilities, systems, and processes with the potential to impact product quality. Project Management can significantly impact project quality, cost, and time through the decisions and mechanisms they choose to implement. Third-party resources and service firms can help with current developments in industry practices and standards and have the potential to more than pay for themselves in terms of money and time saved.

PSC Biotech® Project Management

PSC Biotech® project management experts have a strong track record of delivering projects and offering the best solutions for all kinds of projects in the life science industry. We follow current Good Practice regulations, the Project Management Institute’s Best Practices, and ISPE’s Good Practice Guides. Our Project Life Cycle services include project initiation, planning, execution, monitoring and controlling, and closure. Throughout the Life Cycle of a project, our primary focus is on delivering our project, on time, on budget, and to specifications.

Download the Multi-Disciplinary Validation Teams for GXP Projects White Paper today!

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PSC Biotech provided exceptional professionalism in project planning and time management, qualification document designing, and the executive power of completing qualification tests and solving qualification deviations. 

PSC Biotech® delivered a detailed service quotation including personnel, transportation, and accommodation to our client, a global biopharmaceuticals development and manufacturing company located in Taiwan.

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PSC Biotech provided CQV and Metrology services for this project. Client required rapid use of refrigerated storage trailers to handle warehouse overload. Each trailer required sensor calibration, engineering study for temperature profile, installation qualification, and operational qualification with temperature mapping. PSC consultants performed the calibration, ran engineering studies, wrote and executed qualification protocols, resolved deviations, and closed out reports. 

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