Process Safety Evaluations
Process Safety Evaluation Consultants provide the insight and recommendations to enable enterprises in the life sciences industry to safely scale-up their development work and operate their manufacturing processes with mitigated risks. In the tightly regulated healthcare space, Process Safety Evaluation professionals ensure compliance while reducing operational risks and the probability of incidents.
How do Consultants Evaluate Process Safety?
Process Safety Evaluation consultants do their evaluation on-site or in their certified Process safety laboratory in a comprehensive and data-driven manner. The process safety report presents recommendations to eliminate or mitigate identified risks in your healthcare operations.
What is Evaluated in Process Safety?
Process Safety Evaluation identifies the hazards and control measures including, but not limited to the following process areas.
- Properties of raw material and reaction mixtures
- Properties of intermediary and final products
- Thermal Stability of material and equipment
- Quantity, order of addition of reactants, and the rate of heat generation
- Pressure and gas systems evaluation
- Combustible dusts or vapors
- Chemical or biological hazards
The Process Safety Evaluation report contains the test results and evaluations of the process, recommendations, and the ‘Basis of Safe’ (BOS) operating ranges that you should apply to your Research, Development, Scale-up, Pilot Scale, Clinical, and Full-Scale Commercial manufacturing operations.
Lock-Out/Tag-Out (LOTO) Development
Equipment and machines always have some form of ‘Hazardous Energy’ associated with them and they all need cleaning and maintenance. Lock-Out/Tag-Out procedures are the way that you assure that no one, even the personnel not directly involved in the cleaning or maintenance of the equipment, is injured when people are working on the equipment.
Electricity is not the Only ‘Hazardous Energy’
Hazardous energies include;
How do you Develop a LOTO Procedure?
You develop your Lock-Out/Tag-Out procedures as part of your an industrial safety evaluation performed by experienced consultants or your Environmental, Health, and Safety (EH&S) staff. A LOTO procedure involves the specific steps and training of your staff, contractors, and vendor personnel to use the proper locks and tags, the step-by-step process for installing them, verifying that the equipment is deenergized and safe for work, and the step-by-step process to safely clear the equipment and return the equipment to an energized state.
Process safety evaluations and LOTO save the lives of your staff, keep your workplace safe , and save you the monetary, legal and regulatory penalties that come with worker injuries or deaths. Hiring the right Safety Consultants is always a wise investment, especially if you are planning to install new equipment, scale-up production, or revamp your operations. PSC Biotech provides engineering safety and associated services consultants to make your company operations safer and more efficient.
Connect with us now at https://biotech.com/contact-us/
Regulatory affairs consultants help organizations operating in the life science industry refine and execute their regulatory and compliance strategies, timely submit regulatory dossiers, and achieve positive resolution of regulatory issues. PSC’s regulatory affairs consultants will help you to achieve your regulatory goals while managing the costs of compliance and avoiding the costs of regulatory failures.
Significant law, regulation, and guidance changes in the life science industry and advances in technology make it important for companies to vigilantly review and revise their policies, processes, and systems in order to meet the new requirements. All companies, whether big, small, or yours, rely on regulatory to maintain compliant operations and achieve successful product approvals.
Whether you are trying to develop a regulatory strategy, prepare a submission or response to the Agency, working with PSC’s expert consultant will increase your chances of a favorable outcome. Read on to see the benefits.
Answer Complex Regulatory Questions and Navigate New Regulatory Territory
The life science industry is always contending with new legal and guidance requirements that present complex regulatory issues. Expert consultants help your internal regulatory teams to navigate these complex areas.
From strategy development, tactical execution, or leading audits and conducting remediation and revision projects to make a company compliant with the new requirements, PSC’s experts offer a unique resource. Let us help your internal teams with the insight required to implement and maintain the right new processes, procedures, and systems.
Prevent the Costs of Enforcement and its Expensive Aftermath
Increased regulatory compliance enforcement underscores the importance of effective regulatory compliance. The cost of these preventive measures is always far less than the expensive consequences of enforcement action. A regulatory failure can lead to massive combined expenses that pale in comparison to the costs of effective prevention measures.
PSC’s expert consultants provide objective assessments through a robust system auditing to evaluate the key areas that come under regulatory scrutiny in areas such as GMP, GLP, GCP, Vendor and Supplier Management, Pharmacovigilance, and Data Integrity.
Bring Industry’s Best Practices and Standards
PSC’s expert regulatory affairs consultants have encountered a variety of challenges working in the field; thus, they’ve developed a variety of solutions to address them. They bring in a unique perspective into what will work best while addressing certain problems or preparing for new development. They use their knowledge and expertise while developing the best practices and standards for each organization they work with.
As FDA-regulated manufacturers continue to compete for the top talent in a globalized market while navigating a more complex regulatory environment, PSC Biotech regulatory affairs consultants will continue to offer valuable assistance to plan, execute, and complete your projects quickly, reliably, and cost-effectively. Contact PSC Biotech at www.biotech.com.
Project Management lets you implement your project to meet your specifications, on time, and on budget. Project Management lets you optimize the triple constraints of time, cost, and quality to achieve the successful completion of any pharmaceutical or life science project. PSC Biotech is the right partner for project management!
Globalization has significantly changed how you do business. You must consider global utility for every project. You need Project Management with local attention to the details that make your project globally useful.
PSC’s 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 main focus is on delivering our project, on time, on budget, and to specifications.
Let’s consider key Project Management practices in the Life Science Industry.
Project Management Approach for the Pharmaceutical and Life Science Projects
Apply a project management approach that involves skills application, knowledge, tools, and techniques. This helps to achieve the project’s objectives efficiently. Each project has four essential processes:
It is vital to
identify the requirements early during the project,
set achievable targets keeping the cost, quality, scope, and time in mind,
Identify risk and mitigation strategies, and
Involve and gain approval from key stakeholders.
Use of Information Technology
IT is essential to modern Project Management. Good IT systems enable
- Efficient and Effective project execution and management
- Quick decision making on the basis of recent trend/data
- Market expansion/Increased market access
- Improving customer service
- Risk management
Overcoming Key Challenges in Project Management
The pharmaceutical and life sciences industry is heavily regulated across the globe, which makes it challenging to manage Pharmaceuticals and life sciences projects. Professional project management helps to ensure success and to overcome any of the following challenges:
- Scope identification and management
- Global project execution and management
- Cost, timelines, and budget planning
- Key stakeholder management including the regulatory agencies
- Quality management
- Risk management.
Your local project that is now or soon will be a global project is the new reality in the Pharmaceutical and Life Science industry. Project success means you need to manage locally and think globally. PSC Biotech is ready to provide you the Project Management Services to help make your project a success. Contact PSC Biotech at www.biotech.com.
Data integrity has become crucial to compliance for regulated life science companies. Data Integrity assures the completeness, consistency, accuracy, authenticity, timeliness, and reliability of your data.
Whether your company is a biotechnology startup, pharmaceutical company, blood bank, gene therapy research institute, medical diagnostics facility, food and beverage corporation, you rely on digital data. Data Integrity shortcomings can lead to increased compliance costs to remediate the FDA citations, Warning Letters, and even delay your product approvals.
- Experts recommend that your data integrity program follow the ALCOA+ principles to achieve and maintain data integrity.
- Attributable to the person, system, or data generating the data: What is the source of the data? Who did the data collection and performed the analyses?
- Legible, traceable, and permanent: Is the data readable and understandable? Is it stored in a durable medium?
- Contemporaneous: Where and when was the data created? Was it recorded as it was generated or observed?
- Original: Is it an electronic record or metadata? Have the original records been preserved? Are they easily retrievable?
- Accurate: Is the data error-free? Has it been maintained, updated and modified well?
- Complete: Is all data available? Has anything been deleted?
- Consistent: Has the data been chronologically arranged? Are there date and time stamps on the records?
- Enduring: Will the data last even after 20 years? Will it lose readability after a long period of time?
- Available: Can the data be accessed throughout its lifetime?
- Assess your systems for situations that might lead to data security breaches or compliance issues. Implement proper controls.
- Identify your products and processes with electronic data capture, such as automated HPLC systems, etc., high rates of Out Of Specifications (OOSs), and restrictive stability specifications. Implement appropriate controls for your high risk systems.
- Document results, observations, and discrepancies carefully. Pay special attention to orphan data or excluded data.
- Develop and implement corrective and preventive action (CAPA) plans to eliminate undesirable situations and non-conformities, and to improve data integrity.
Our team at PSC Biotech™ understands the data integrity responsibilities and provides audit and remediation services for data integrity.
Our insightful audit reports promote effective data integrity and record management strategies, and encourage data protection and privacy. We ensure our clients meet the standards set by the U.S. Food and Drug Administration (FDA), the European Commission (EC), an regulatory Agencies throughout the world. Whether you do research and development, clinical trials, quality control, manufacturing, data management or inspection, PSC Biotech™ can help you establish, evaluate, and improve your data integrity.
Convinced yet? Give us a call or visit www.biotech.com for more information.
Written by: Crystal Booth, M.M.- Regional Manager, Southeast USA at PSC Biotech
We’ve probably all heard the phrase “audit ready state”. But what does it really mean? How do you get to and maintain an audit ready state? An audit ready state is simply operating in a way where you are ready for an audit at any time. This may be a client audit or a regulatory audit.
One of the best ways to get into an audit ready state is to perform internal audits and self-audits on a frequent basis. Have different individuals and quality assurance look over operations, processes, and physically walk-down areas e.g., Gemba Walks, etc. Take findings seriously and implement corrective and preventative actions. During self-audits look at labeling, cleanliness, expiration dating, documentation, logbooks, equipment calibrations, reagents, blocked isles, waste bastes, incubators, etc. You want to systematically look at your area of responsibility and pretend you are a regulatory auditor. What would the auditor see? Your goal is to find and correct potential findings. What you find and fix are audit observations proactively dealt with. It is better that your internal audit systems find potential observations and implement solutions than for clients or regulators to find your weaknesses.
Tools, such as 6S (Sort, Set In Order, Shine, Standardize, Sustain, and Safety), will help to ensure that everything is clean and in place. Frequent self-auditing and adherence to 6S principles gives you constant feedback and allows you to adjust processes where needed to ensure you are consistently audit ready. Remember, don’t wait for “them” to find your weaknesses.
Another tip is to be in an “audit state of mind”. This means developing the mindset to pursue top-notch quality on a daily basis and embrace the concept of continual improvement.
Need help getting started? PSC Biotech™ provides custom programs to help companies get to a compliant audit ready state. Experienced consultants are available to perform audits of your facility and processes to help ensure your current processes and quality systems are compliant.
PSC Biotech™ offers a wide variety of solutions to ensure success for any size company, including consulting, risk assessment, writing standard operating procedures, protocols, and white papers, project management or complete turnkey project services to execute projects to free up your company’s valuable resources. Whatever your needs may be, PSC Biotech™ is here to help. Give us a call today!
Calibration and Validation are critical regulatory requirements of the Life Sciences Industry.
If you are looking for Calibration Services, Calibrated Equipment Rentals, or Validation Services, contact PSC Biotech at www. Biotech.com.
FDA defines validation as “…a process that is required to establish documented evidence to assure that a specific system, equipment, computer system, or process will consistently meet the requirements and its intended use.”
All organizations need to validate their systems, computers, equipment, and processes that have GMP impact.
Calibration is the process of determining the accuracy of the measurement system over its intended range of use against the defined standards. Life science companies calibrate their instruments to measure process parameters.
- Relative Humidity
Are Validation and Calibration Different?
Yes. You can’t validate unless you calibrate first! Calibration assures the accuracy of your measurements. Validation uses your measurements with your calibrated instruments to provide documented evidence that whatever you are validating meets your user requirements for its intended use. Whether it is calibration or validation, PSC Biotech can meet your needs.
PSC BiotechTM Metrology is our Metrology laboratory and pharmaceutical validation service with experience and skill in serving the life science industry across the globe. PSC Biotech Metrology provides calibration services and rents calibrated equipment to ensure that your facility stays Gap compliant.
Our Metrology Unit offers the following range of services:
Instrument Calibration Services:
- Calibration of temperature, humidity, pressure, and mass
- Metrology plan review and preparation
- Field instrument calibration
- Reference instrument calibration
Calibrated Equipment Rental Services
- Kaye® Validators, LTRs, HTRs, SIMS
- Lives® International Wireless Data Loggers
- Ellabs® Wireless Data Loggers
- Cryopack® Wireless Data Loggers
- CLiMet® Particle Counters
PSC Biotech also provides the professional services to execute your validation program.
- Reviewing and preparing for the validation master plans
- Gap analysis and risk/impact assessments
- Qualification and validation, including validation plans, design, installation, operational and performance qualifications
- Support to implement remediation program
- Equipment commissioning (factory and site acceptance tests)
Process and Quality Support
- Third-party and supplier assessment, qualification, and auditing
- Remediation plan management
- Risk and gap analysis support
- Cleaning process development and validation
- Technology transfer support
- Regulatory support for the preparation and upgrade of document types
- Processes and primary packaging validation
- Inspections and audit preparation along with annual product reviews
- GMP support (i.e., variations and deviations management)
- Internal processes analysis to boost the efficiency of the company
If you are looking for Calibration Services, Calibrated Equipment Rentals, or Validation Services, contact PSC Biotech at www. Biotech.com