PSC Biotech Singapore is a full service organization capable of providing a complete team of qualified personnel to work on your project(s) including Engineering, Information Technology, Technical Services, Validation services, Compliance and Qualification, Regulatory Submissions, Clinical, Project Management and Quality Assurance, or PSC can supply individuals with specialized expertise to supplement your internal workforce.
Commissioning, Qualification, Validation
We pride ourselves in providing comprehensive regulatory compliance and qualification services. Our services include strategic planning for validation, commissioning and qualification activities – which include Equipment Qualification, Computerized Systems and Software Validation, Process Validation, Cleaning Validation, and Analytical Method Validation.
Computerized Systems or Software that perform GxP related functions in the Life Science industry must be qualified or validated. Computerized Systems may include networks (wired and wireless), workstations, operating system & application software, instrument software, equipment automation software, and any interfaces to other GxP systems. PSC Biotech Pte Ltd. offers a complete range of services for your computer validation needs.
Our computerized systems and software validation services include but are not limited to:
Process Control Systems (PCS)
Building Management Systems (BMS)
MS Excel Spreadsheet
Laboratory Information Mangement Systems (LIMS)
Management Systems (EDMS)
Process Validation combines the actual validated facility, utilities, equipment, and the trained personnel with the commercial manufacturing process, control procedures, and components to produce commercial batches. A successful process validation will confirm the process design and demonstrate that future commercial manufacturing process performs as expected. Process Validation will typically have a higher level of sampling, additional testing, and greater scrutiny of process performance than would be typical of routine commercial production. The level of monitoring and testing should be sufficient to confirm uniform product quality throughout the batch.
PSC Biotech Pte Ltd. can offer assistance with Process Validation. Our skilled personnel can work with your operations and quality groups to generate process validation protocols, facilitate execution, collate documentation and generate reports. Our consultants can provide advice on Process Simulation testing, environmental monitoring during process validations, and regulatory requirements with respect to batch sizes and the number of replicate runs.[/tp]
There has been increased regulatory scrutiny on validation of analytical methods. PSC can assist you in the validation of analytical methods to meet ICH standards. We can also support you in the validation of test methods required for your stability studies and cleaning validation studies. Our experts will help you to identify the relevant validation requirements.
Code of Federal Regulations (CFR) 311.165c states that “the accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm shall be established and documented.”. This means that the method used in laboratories should not only be reviewed but tested so they comply with the regulatory specifications. We will help your company develop methods that you can use to test your product to be of consistent quality from development to production. With PSC, your test methods will be accurate, precise, specific, robust, able to detect parameters, able to quantify parameters, linear, and have a defined range.
The objective of cleaning validation is to provide documented evidence that a specific cleaning process will consistently clean to predetermined limits, to prevent contamination that could adversely affect the safety, efficacy, purity and quality of the products. Therefore, implementation and validation of cleaning procedures are essential.
PSC Biotech Pte Ltd. can help you with all aspects of your cleaning validation program, from cleaning procedure feasibility to determining detection limits of analytical methods used for testing. We have extensive experience in developing scientifically defendable acceptance criteria and ensuring the execution is conducted in an orderly manner. We can deliver a complete cleaning validation package, from development and execution of protocols to the creation of standard cleaning procedures, cleaning logs and training documentation. We provide guidance in selecting and evaluating effective cleaning methods and processes with the complete understanding of regulatory requirements, guidelines and expectations.
Validation Master Plan/ Qualification Plan forms the cornerstone of validation approach and serves as the principal document for regulatory inspection. It provides all parties with a precise overview of their roles and responsibilities and aligns the execution methodology so that the validation process runs smoothly.
PSC Biotech Pte Ltd. has experts from many different disciplines including Facility Engineering, Process Engineering, Microbiology and Quality Assurance with strong GMP, GLP, GAMP 5, ISO and 21 CFR Part 11 regulations knowledge. We understand your processes and expectations and can help you with the realistic planning of attainable validation goals.
We can identify and help you to eliminate repeated work using an integrated commissioning and validation risk-based approach, to produce a comprehensive validation plan. We can supplement this with an extensive traceability matrix that allows you to demonstrate compliance and comprehensive testing, and that can also be used to support change through the life of the system. In addition, we can help you to ensure that all your validation lifecycle documents: supplier documents or protocols generated in-house are consistent with the Validation Master Plan/ Qualification Plan.
We offer fast documentation turnaround and our strength in depth allows us to execute fast track validation projects. With our extensive experience and protocol library, we are able to offer lower cost solutions which still remain compliant.
We provide high-quality qualification and validation services in the pharmaceutical, biotech, medical devices, diagnostics, consumer products, cosmetics, R&D Labs and veterinary industries. The scale varies from qualification of a single piece of instrument/equipment to a complete turnkey project. We have been engaged in the validation of start-up facilities, facility expansion, facility and system upgrade or simply annual requalification.
From Commissioning or in some cases, as early as design phase to Performance Qualification we are driven to provide documented evidence that analytical instruments, process equipment, classified environments, containment solutions, and clean utilities are fit for their intended use
We advise customers based on industry trends and best practices, or if you have established methods and protocols, we can tailor our services to suit. Whether it’s executing a client’s protocol or executing a protocol that has been custom produced by PSC, our validation engineers can provide quality on-site protocol execution services. We have expertise in GMP documentation practices and change control procedures. And we understand the importance of following your SOPs. Our approach can deliver substantial improvements in compliance while minimizing downtime and maintaining the highest assurance of product quality and safety.
If you are in storage, transportation and distribution of starting material and medicinal products business then you are abided by Good Distribution Practice. We can help you to ensure the quality and integrity of your product is maintained throughout the complete supply chain. We conduct a thermal performance test and product stability test of your packaged product both under simulated and actual distribution conditions. We can assist you in determining the most appropriate packaging configuration by performing temperature mapping and package optimization studies. We can help to qualify your warehouse, logistics and transportation facilities to ensure they meet Good Distribution Practices.
Engineering, Project Management
We have experience in design and reviewing engineering design at every stage in a project lifecycle. Being an independent party, we can help you to ensure your designs are fit for purpose and meet regulatory requirements.
PSC Biotech Pte Ltd. has experience in design and reviewing engineering design at every stage in a project lifecycle. Being an independent party, we can help you to ensure your designs are fit for purpose and meet regulatory requirements. Our capabilities include:
Checking, Approval and Verification of Design
HAZOP and CHAZOP Evaluation
Vendor Drawing Reviews
System Boundary Mark-Ups
We can help you to coordinate with relevant agencies to resolve issues and speed up approvals, set-up & implement regulatory standard operating procedures, and handle day-to-day regulatory operations while providing expert advice on regulatory strategy.
PSC Biotech Pte Ltd. has consultants with extensive regulatory submission experience, who could assist you in
BLA, NDA, ANDA, PMA and 510k
PSC can advice you on the requirement and formats of Biological License Application (BLA), New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Premarket Approval (PMA) and Premarket Notification (510k) documents. We can help you prepare, assemble and review the required documents and reports. At PSC, we know how important it is to you to expedite the FDA review and get your product to the market faster. We strive to maintain a relationship of mutual trust and respect with regulatory agency personnel and to develop a pattern of proactive communication with agencies to promote timely decision-making and progress towards completion. With our continued positive interactions with regulatory agencies, we can help you achieve your goals faster.
Drug Master File (DMF)/ Active Substance Master File (ASMF)
We can help you to • File Letters of Authorization •Maintain Customer List •Create DMF/ ASMF • Update your active substance Annually to DMF/ASMF. You will be relieved of the complexities of Investigational New Drug Applications (IND), NDA, ANDA, Export Application, or amendments and supplements to any of these while your DMF/ASMF is under our care.
Chemistry, Manufacturing and Controls (CMC) related submission
We can help you prepare, assemble and review the required documentation and reports tailored to suit the substance submitted for IND, NDAs, ANDAs and Annual reports. We can also handle CMC-related queries from US and international health authorities and coordinate and participate in meetings with relevant authorities to resolve scientific technical or regulatory issues resulting from a review of submission or compliance action.
It starts with a well managed inspection. Inspectors expect that the applicants understand and demonstrate FDA regulations through documented evidence, personnel interaction and site visit. What is more effective than having an external organization perform a mock inspection?
At PSC, we have former FDA employees with extensive auditing experience and employees who are capable to do just that. In addition we could:
Deliver an effective briefing of PAI flow
Give insights to escorts (inspection coordinators) and Subject Matter Experts (SME) on how to face the inspectors appropriately
Assist in preparation of Quality System documents and records of products for inspection
Give tips on DOs and DON’Ts during the inspection
Are you looking forward to:
Enhance customer satisfaction?
Improve customer focus and process orientation within the organization?
Facilitate continuous improvement?
Create consistency throughout the organization?
Strengthen relationships between the organization and its customers and vendors/subcontractors?
Instil confidence in customers, about your ability to consistently meet quality requirements?
Then you are looking at obtaining ISO accreditation. For your information, PSC Biotech obtained ISO9001 in the Year 2008 and are preparing for ISO17025 accreditation. At PSC, we have the right expert who can provide you the ONE STOP solution:
Perform gap analysis on the existing quality system
Implement the requirements of desired ISO accreditation by adding and documenting systems and processes
Inform the selected registrar to come for audit once the quality system is in place
Assist in an annual surveillance audit
Assist in 3 yearly QMS audit
Maintenance of ISO accreditation status
Our services include sharing our in-depth industry knowledge and experience to deliver project-wide, plant-wide or company-wide compliance management and quality management that are cost-effective and distinct to your company’s operations, values, business focus and culture.
PSC has a fully validated ISO 9001:2015 certified Quality Management System (QMS). We manage our business processes from end to end. Each process is controlled and can oversee to reduce the risk of data manipulation or loss. This allows our stakeholders to be on one platform and in control of our quality.
Auditing & Compliance
PSC offers professional guidance and consulting for meeting required regulatory requirements and international standards ie. USA FDA, EU EMEA and the GxP’s. Our compliance services include Gap Analysis, Risk Assessment, Internal Audits, Supplier Audits and Data Integrity Analysis.
Establishing a compliant quality system can be a daunting prospect for any organisation. Knowing where to start is often the biggest hurdle in putting together a successful implementation plan. Balancing the effort against cost and risk can be a delicate task.
PSC Biotech Pte Ltd. offers a comprehensive auditing and gap analysis service. We will work with you to review your existing systems, identify any gaps against regulations, and help you to prioritise and eliminate gaps to achieve compliance through:
Determination of Corrective Actions and Preventive Actions (CAPA)
Improvements to your quality system
Training of your team
Retrospective validation support
And utilising our multinational team, we are able to support this process in English, Chinese, Vietnamese, Tamil, Malay, and Spanish amongst other languages.
PSC Biotech Pte Ltd. has extensive experience in auditing GxP companies. Our staff of seasoned professional auditors have experience with FDA, ISO, and international regulatory agencies. Our staff is trained in:
Helping firms carry out mock FDA or ISO inspections at your facility
Part 11 compliance with the computer system and software
Third-party audits of vendors, suppliers
Outside testing services
Our audits help you identify those areas where there are shortfalls in compliance. Whether it is a one-time audit or a recurring periodic audit, you can be assured that we listen to your needs and keep the focus where it belongs – on your requirements. Our audits help you by:
Creating an integrated auditing process aligned with your internal goals and supplier commitments
Conducting mutually beneficial audits for both you and your suppliers
Our international team can reduce your rising travel expenses
Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.” … ICH Q9
Risk Assessment is performed throughout the product lifecycle and involves risk assessment, control, communication and review. Our industry seasoned consultant can help you to perform risk assessment utilizing the correct risk management tool and recommends the risk control or mitigation measures. We can create a robust risk management process tailored to your context and helping you to meet the regulatory requirement.
Undesirable inspection finding? Been issued an FDA 483? Warning Letter? Product Recalls or Injunction? PSC can help you to better respond to the compliance bodies. Being an external organization with professional staff in handling regulatory responses, we can easily identify and address the issue which is not in compliance. We can assess each observation, develop an action plan to achieve immediate, short-term and long-term correction and to prevent recurrence. We can assist by collecting and collating data, preparing and revising draft reports, coordinating the review process, and finally submitting the reports with appropriate forms and cover letters to the regulators. At the end of the day, it is TRUST that PSC wants you to establish with the regulatory bodies.
We offer customized GMP and compliance training programmes to meet your specific regulatory and business needs from individual to group sessions on your terms. We implement highly interactive programmes incorporating contemporary adult learning techniques to assure that your employees absorb and retain the material and can apply them to their work.
PSC Biotech provides training in quality systems, compliance, product development and validation for the pharmaceutical, medical device, and biologics industries. Our programs are enriched by the expertise of trainers that include former FDA, EU, and industry professionals who are recognized authorities in the areas of QSR, GMP, ISO, FDA compliance, GCP, GLP, product development, and validation. Our programs include current industry “best practices” and are designed to address all pertinent US and international regulatory requirements. We implement highly interactive programs incorporating contemporary adult learning techniques to assure that your employees absorb and retain the material and can apply them to their work. PSC also offers customized training programs to meet your specific regulatory and business needs from individual to group sessions on your terms.