Blog Archives – Life Science Services and Solutions Provider

A Penny Saved is a Penny Earned. The Importance of Staying on Track and on Project Costs on Large Complex Projects

Mar 4, 2021 | Blog

Written by: Chandler Conley, Business Development Manager

Pharmaceutical industry projects are some of the largest and most complex many of us have ever seen. We all have a goal to supply safe and cost-effective therapies and products, which is why it is critical to stick to pre-determined budgets and schedules at all costs- pun intended!

The question is, how is a project cost determined? One way is to consider similar projects as a baseline and point of reference. Did that project stay on budget? Is the cost realistic? How are the deliverables, scope, and processes in this prior project different from the project you are planning for? The process of staying on budget starts in the initial budgeting, proposal, and planning process. Invest the time to be clear about the scope of work for all parties involved and always try to be as realistic as possible to set the team and yourself up for success. Think about what steps are contingent on other steps… will the manufacturer of a piece of equipment have the equipment and accessories delivered in time to meet your deadlines? Are you giving your quality department enough time to review any documents they should? Will any materials or documents that you need to provide the project team be ready by the project start date? Also recall how long safety and onboarding will take for any new employees hired for this project, as this is frequently overlooked in project schedules.

If you are outsourcing support to any service providers and requesting proposals, your point of contact is thinking about these things and also trying to develop a realistic proposal and schedule for you. I promise- they want to go over budget even less than you do!

A fundamental part of project costs are hourly rates. This is a double-edged sword. Having a senior/experienced person may be able to complete a task in less time, which is helpful for project schedules and will result in less labor hours charged. That being said, mixing in multiple experience levels can ensure that people with the appropriate experience level are doing the required tasks. There may be some entry level tasks associated with the project, such as document control support and administrative tasks, so these can be good areas to save some money and utilize staff that are more junior.

We find it is important to allow time for project management in a capital project, so budget should also be reserved for this. Once a project is rolling, a strong Project Manager will manage deliverables and schedules for you and can give regular updates on the project burn rate. They can also be your primary point of contact for the project. Hypothetically, if a team of 10 people are involved, you either have to communicate updates for changes to all 10 people, or you can communicate to the Project Manager who can then ensure the rest of the team gets the communication without taking up any more of your time, which is the option we recommend.

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How Can PSC® Help You Succeed During COVID

Feb 26, 2021 | Blog

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

The COVID pandemic of 2020-21 has impacted the Life Science companies in myriad ways. The greatest impact has been on companies to develop ways to continue to produce their life-saving products, not just COVID related products, with all of the restrictions, supply disruptions, and other pandemic factors. The onset of the pandemic brought the need to rapidly develop, manufacture, and distribute large amounts of diagnostic devices, vaccines, and other therapeutics for COVID. The FDA and other regulatory Agencies have responded using their Emergency Use Authorization (EUA) and other authorities to make resources available to combat the pandemic and keep people healthy.

In the pandemic aera, speed saves lives. For example, a typical vaccine development and manufacture process including the R&D phase, Pre-clinical trials, Phase I, II, and III trials, FDA review and approval, commercial manufacturing and distribution takes about 73 months to completion. The COVID diagnostics and vaccines were built on technology that was already developed and the specific vaccines and diagnostics were developed and scaled to produce hundreds of millions of doses in less than a year.

The US government initiated Operation Warp Speed (OWS) to accelerate the vaccine distribution and administration process. OWS supports private industry with overall coordination of the pandemic response effort, logistical support, personnel support, and resources to assure that every one of the almost 370 million American who wants a COVID vaccine, needs a COVID test, or needs treatment for COVID infection gets what they need as fast as possible. The current vaccines require two doses, so industry has to make and distribute and the health care system needs to administer almost 800 million doses of vaccine.

All of this is easy to do on a small scale, but when you have to do it 800 million times, that’s where the challenges arise.

Throughout the pandemic, we at PSC Biotech® have been offering our expertise and providing variety of solutions to help companies continue to execute their mission, be it COVID vaccines, diagnostics, or therapeutics or just being able to continue to supply your life saving products to your customers. PSC Biotech® provides professional services solutions that include:

Computer Systems Validation (CSV): Electronic Document Management Systems, Data Integrity, Laboratory Equipment Software Validation
Quality Assurance and Compliance support: QA Reviews (GLP, GMP, GCP), 483/ Warning Letter Remediation, Risk Assessments, Microbiology Laboratory consulting
Technical Writing: FDA Responses, SOPs, documents, Forms, Protocols
Regulatory Affairs: NDA/BLA/ANDA/INDA/510(k)/PMA submissions, Pre-approval and post- approval support, Regulatory agency Interaction consulting
Commissioning, Decommissioning, Qualification and Validation (CQV)
Calibration: Equipment Rentals, Validation, Instrument Calibration, Process and Quality IT support, SQE support
Audits: Supplier, Laboratory, Facility, PAI preparation, Gap Analysis
Project Management
Engineering support: Facility Optimization, Equipment Selection, Process Design and P&ID

PSC Biotech® also offers a fully validated, integrated, electronic Quality Management System (eQMS) software solutions called ACE® (Adaptive Compliance Engine®), the turn-key eQMS solution, ACE Essentials™, and AuditUtopia®, the world’s easiest to use audit hosting and management software to help your company not just to survive COVID, but to prosper in these challenging times.

Contact us if you need support with any of these services to help you accelerate your success!

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How Poor Compliance Impacts Your Bottom Line

Feb 18, 2021 | Blog

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®

Life science companies need to comply with laws, regulations, and Agency guidance. Compliance requires understanding processes and technologies and ensuring that quality is built into your process and product. Compliance means you have the documentation that proves the quality of your product and processes. When you have compliance issues, you spend your time and your money fixing them, raising your costs and lowering your output.

The figure below shows FDA 483 citations related to various quality and compliance issues.

®Key compliance issues observed in 2020 include the following.

Absence of written procedures and clear SOPs (21 CFR Part 211): This is most observed compliance issue. Specific compliance deficiencies include lack of written procedures, ambiguity with respect to roles and responsibilities assigned, complex language in SOPs, failure to timely update SOPs, and lack of proper description of the steps in the operations.
Improper Data Management (21 CFR Part 11): This compliance failure relates to lack of proper data systems that can appropriately use, store, retrieve or archive data efficiently. You need to develop and maintain data management systems that properly manage and control your data.
Lack of control procedures (21 CFR Part 211): Another common issues is inadequate control procedures, whether the absence of control of control procedures for batch controls, in-process controls, laboratory controls, labelling control, etc.
Inadequate Cleaning, Sanitization, problem of cross contamination (21 CFR Part 211.67): You need to maintain proper procedures for cleaning and sanitization. Inadequate cleaning protocols can be a direct cause of contamination. You also need to prevent cross contamination from other products or raw materials in production and storage areas and holding areas for active pharmaceutical ingredients, intermediates, finished drug products and container closure systems.

Procedures are just one part of compliance. Procedures don’t work by themselves. You need personnel trained for the specific operations.

Companies with strong quality compliant procedures, documentation, and trained personnel consistently achieve the highest compliance to laws, regulations and guidance’s and produce products with the highest quality, safety and efficacy.

PSC Biotech® offers an array of professional services, including Quality Assurance and Compliance Gap Assessment and Remediation, Auditing, Calibration, Technical Writing for procedures and SOPs, and Regulatory Affairs advice. PSC’s® software solutions such as ACE® (Adaptive Compliance Engine®) and ACE Essentials™ are fully integrated, validated, centralized electronic Quality Management Systems that have been in use by various life- science companies to manage essential aspects of quality systems and ensure compliance.

Call us today to explore the right solution for your needs.

References:

21 CFR (Code of Federal Regulations) Part 211 (Current Good Manufacturing Practice for Finished Pharmaceuticals), Part 210 (Current Good manufacturing practices in manufacturing, processing, packing and holding of drugs), Part 11 (Electronic Records: Electronic Signatures), Part 820 (Quality System Regulation)
Annex 5, World Health Organization, Guidance on good data and record management practices
ICH Q7 guideline: Good Manufacturing practices for Active Pharmaceutical Ingredients

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FDA Combination Products Q&A

Feb 11, 2021 | Blog

Written By: Jorge Sugranes, Regional Director of Latin America, PSC Biotech

Here are some Q&A regarding combination products (CP) that you might like. I found this information, published by the FDA*, very helpful, educational, and clarifies common questions about CP.

*Reference: fda.gov

How are combination products assigned for review?

Combination products are assigned to FDA center that will have primary jurisdiction for its premarket review and regulation. Consistent with section 503(g)(1) of the Act, assignment to a center with primary jurisdiction for premarket review and post-market regulation, or a lead center, is based on a determination of the “primary mode of action” (PMOA) of the combination product. For example, if the PMOA of device-biological combination product is attributable to the biological product, the Agency component responsible for premarket review of that biological product would have primary jurisdiction for the combination product.

Section 503(g) defines primary mode of action as “the single mode of action of combination product that provides the most important therapeutic action of the combination product” (see also definitions at

2 CFR 3.2. In some cases, the most important therapeutic action cannot be determined. For example, combination product may have two independent modes of action, neither of which is subordinate to

the other. To resolve these types of questions, FDA’s regulations at 2 CFR Part 3 include an algorithm for determining center assignment. The algorithm directs center assignment based on which center regulates combination products raising similar types of safety and effectiveness questions, or, if there is n such center, based o which center has the most expertise to evaluate the most significant safety and effectiveness questions raised by the combination product.

What is the process for obtaining an Agency decision regarding the classification or center assignment for my medical product?

Sponsors may request formal assignment through the Request for Designation (RFD) process or alternatively obtain informal non-binding feedback regarding their combination product or product through submission of a Pre-Request for Designation (Pre-RFD).

How do I submit a Pre-Request for Designation (Pre-RFD)?

The Pre-RFD process is available to provide informal, non-binding feedback o whether a medical product is a drug, device, biological product, or combination product and/or the Center to which it would be assigned. Sponsors may contact OCP (i.e. at combination@fda.gov for information about how to submit a Pre-RFD. Additionally, OCP recently published a draft guidance about Pre-RFDs that may be helpful.

What types of marketing applications are required for a combination product?

Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the primary mode of action (PMOA) for the combination product (i.e., a new drug application (NDA) or abbreviated new drug application (ANDA) if it has a drug PMOA, a biologic license application (BLA) if it has a biologic PMOA, or a premarket approval application (PMA), de novo classification, or premarket notification (“510(k)”) if it has a device PMOA). A single marketing application is generally sufficient for combination product. In some cases, however, a sponsor may wish to submit separate marketing applications for different constituent parts of a combination product, and FDA may consider this permissible.

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Lives International® Temperature Logger Solution

Feb 4, 2021 | Blog

Written By: Paige Curtis, Marketing Specialist, PSC Biotech®

The COVID-19 vaccine requires storage in a controlled environment at ultra-low temperatures ranging from -123°F to -49°F (-86°C to -45°C). Due to the huge demand for vaccines across the world, companies are turning towards freezer farms, facilities of deep freeze units, to store the vaccine.

Lives International® Temperature Loggers are GMP compliant and are designed to validate ultra-low freezers for the storage of vaccines and any other products that require temperature control. These loggers are highly efficient and speed up the process of validating these freezers and chambers. An additional benefit to this data logger is it highly reliable and has the accuracy you need to minimize uncertainty. The data logger increases transparency by sending the data in real-time and bringing the flexibility of remote controls.

Lives International® Temperature Logger Solutions are easy to program and install. Multiple users can share the data base at the same time while no data is lost during the validation process.

Our team at PSC Biotech® is able to provide an effective solution to tracking temperature with Lives International® Temperature Loggers. Save time without sacrificing the importance of compliance when dealing with the COVID-19 vaccine.

Contact us today to find out more about Lives International® Temperature Logger Solutions.

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Why is Data Integrity Vital

Jan 28, 2021 | Blog

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech Corporation

Data Integrity is a point of emphasis for the US FDA. That means they will always look at your data integrity program.

FDA expects that your data integrity program assures the accuracy, consistency, and completeness of data throughout a product life cycle, right from the conception of the document until its archival and destruction. FDA expects that your data and your meta-data (the data about the data) will be ALCOA, that is attributable, legible, contemporaneous, original, and accurate. When your data and meta-data are also complete, consistent, enduring, and available your meet the ALCOA+ (1-2). These data integrity principles apply to both paper and electronic records. Your company needs to develop data integrity systems that assure your data and meta-data are ALCOA+.

The reason why data integrity has become so important in recent years is due to the many cGMP violations that have surfaced involving these issues. These violations usually result in FDA Warning Letters, 483 citations, or other regulatory actions.

Data integrity is a critical step in analysis, strategy, and implementation of any process or system that creates, uses, stores, or retrieves data. If you cannot maintain integrity of data, you can’t prove to FDA that you can maintain high quality, uniformity in the process, and safety and efficacy of your products.

There are 3 backbones for Data Integrity

A Quality Management System
Sound principles and policies
Good documentation practices (GDP)

Your company should adhere to basic Data Integrity practices.

Ensure data is documented at the time of performance.
Implement a quality compliant culture within the company.
Train personnel involved in the processes to timely record data at every step in a product life-cycle.
Make sure that all data recorded is complete and accurate.
Make sure that documents are stored as “true copies” or “original records” or “effective versions”.
Ensure that there are systems (paper or electronic) in place to store true copies or records that indicate the current protocol or process being followed in the company.
Store data and meta-data to prevent deterioration or loss. While paper systems are also used by many companies for storage of data, electronic systems are the most beneficial when it comes to storing data in the desired format, easy accessibility, centralized database, as well as proper archival.
Store backup data in its exact and complete form.
Ensure stored data is secure from any sort of alteration, erasure, or loss.
If you use an electronic system, use a validated electronic system or validate your electronic system. Electronic systems make it easy to create, edit, process, store, retrieve, and archive data, with a full 21 CFR Part 11 complaint audit trail to track activity.

Sound data integrity policies and systems ensure that companies deliver good quality, safe and reliable product with lowest rate of variation.

PSC Software™ has software solutions such as ACE® (Adaptive Compliance Engine®) and ACE Essentials™ that are fully integrated, validated, and fully configurable electronic Quality Management Systems that give you data integrity and adapt to how you run your quality systems and business. Life-science companies across many countries use PSC Software products to implement data integrity principles and maintain regulatory compliance.

Call us today to explore the right solution for your needs.

References

FDA, Data Integrity and Compliance with CGMP, Guidance for Industry
World Health Organization: Guideline on Data Integrity
21 CFR (Code of Federal Regulations) Part 210 (Current Good Manufacturing Practice in Manufacturing, Processing, Packing or Holding of Drugs), Part 211 (Current Good Manufacturing Practice on Finished Pharmaceuticals), Part 212 (Current Good Manufacturing Practice for Positron Emission Tomography Drugs)

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