Pious Labs Provides Consultancy and Regulatory Compliance Solutions
Why Choose PIOUS LABS?.
Continuous Improvement leads to Quality Assurance Only by continuous vigilance on performance can the quality of the product be assured. Management and plant operators need to know at all times how their production processes, equipment and personnel are performing. To achieve this, PIOUS LABS can help you examine all aspects of the company’s production, facilities and personnel. As an independent third-party, our audits are not impaired by company politics or culture. As a result we will present an objective report.
Benefit from an experienced, multinational team supporting you with any regulatory issues you may have. This includes.
1) Quality Assurance Consultancy
Pious Labs will review, update or advise on QA systems. If necessary, an entire QA concept can be developed; support can be provided for its implementation, maintenance and monitoring.
In particular, Pious Labs are able to assist in the preparation of Quality Assurance handbooks which can be either custom-designed or modelled on the requirements of ISO 9000
2) Documentation Support
Pious Labs can advise on all aspects of control and manufacturing documentation. This can include the initial planning of a basic documentation system, through to actual preparation of documents required by the client.Pious Labs are able to supervise and subsequently review the translation of any pharmaceutical documentation in English, Hindi.
Do you have confidence in the quality of your manufacturing SOPs? Many companies do, yet “Inadequacy of Written Procedures” constituted four of the top six GMP pharma deficiencies cited by FDA last year. And what about the SOPs on the clinical side of the business? Are your study oversight procedures flexible enough to accommodate a risk-based monitoring strategy?
SOPs are not easy to write. You need them to be clear and concise, but you need them to describe complex procedures, supplement training, demonstrate compliance, and provide you legal protection. SOP templates that you can download from the web are a decent start, but they fail to reflect your process flows, your unique way of doing business.
Pious Labs has decades of experience writing SOPs for investigative sites, sponsors/CROs, IRBs, nonclinical laboratories, and manufacturing facilities. We begin by looking at your existing processes to make sure they comply with current regulations and guidelines, and are aligned with industry best practices. From there, we can develop new SOPs for you, or revise your existing ones. Afterward, we can create customized training courses to educate your staff on your company’s procedures.
Contact us and we’ll make sure your SOPs are the right fit for your site, lab, or facility.
Pious Labs can assist in the Registration process, both with in-house expertise as well as contacts throughout the India.
Pious Labs can provide assistance in preparing Drug Master Files, Product Licence Applications, Establishment Licence Applications and Pharmaceutical and Analytical expert reports, for US FDA and European Regulatory requirements.
4) Contract Service Evaluation
The use of contract services, either for testing, is increasing. Current GMPs place the responsibility for assuring the quality of such activities on the Contract Giver.
Pious Labs will evaluate contractors for compliance to GMP/cGLP and will provide an independent assessment of the quality of the services on offer.
Validation continues to make ever-increasing demands upon company resources. Pious Labs will develop validation programmes for all critical pharmaceutical equipment, installations and processes.
Upon request, Pious Labs will supervise the implementation of a validation programme and provide practical support to complete the work in the most cost-effective and timely manner.
6) Pharmaceutical Engineering Projects
Pious Labs can provide a full service from initial facility design, through project consulting, project management, installation and validation, all to recognised Regulatory requirements.
If called upon, Pious Labs can arrange for the purchase, installation and validation of pharmaceutical analytical equipment.
7) Regulatory Affairs
Pious Labs assists in the registration process, both with in-house expertise as well as via contacts throughout the world. Overall we provide assistance in preparing Drug Master Files, Product License Applications, Establishment Licence Applications and Pharmaceutical and Analytical expert reports, to meet US FDA and European Regulatory requirements.
Drug Master File (DMF)
- Compilation of European Type A, C, D
- Drug Master Files
- Preparation and submission of Certificates of Suitability (CEP) for pharmacopoeial substances to the EDQM for approval
- Compilation of US FDA DMF documentation for actives, excipients, packaging materials etc.
Site Master File (SMF)
- Compilation of European (PIC/S) Site Master Files for submission to the Regulatory Authorities13
- Planning of the Market Application strategy
- Compilation of the CTD registration dossier/submission and support of the MAA during the review period
- Preparation of the Expert Reports required by CTD Module 2
- Assistance in addressing MAA questions and concerns from the Regulatory Authorities
- Preparation of post-approval change documentation (EU Type 1/2) to an existing market authorisation
8) FREE-TO- USE SOP’S AND TOOLS
SOP&’s and Tools are an essential tool for any pharmaceutical organization. We provide our clients with these tools to encourage them to spend more time documenting by adjusting our SOP’s and Tools to fit their needs.
9) AUDITING & SUPPLIER QUALIFICATION
PIOUS LABS offers comprehensive auditing services for the cost-effective and efficient planning, execution and reporting of your supplier audits.
Globalization continuously adds to the complexity of the pharmaceutical supply chain, for example due to outsourcing of products and purchase of APIs in Asian countries such as China and India. Authorities increasingly emphasize the need for tighter control on the supply chain, a quest fed by discoveries of malpractices and manufacturers operating below acceptable compliance levels.
Supplier audits are an essential tool in supply chain control and many companies currently face the challenge of managing an increasingly extensive and demanding audit program, while keeping the cost under control. This requires an efficient approach to the program and the input of experienced and knowledgeable auditors.
The Advantages of Our Auditing Services
Pharmaceutical companies are facing an ever-increasing amount of regulatory pressure from the FDA,NABL,BIS,APADA and other national regulatory authorities. These regulatory authorities regularly conduct inspections that can lead to a halt in many areas such as QC. We believe in preventative measures that can save your company painful GLP repair projects and as a result: save time while you maintain focus on revenues, rather than crisis-management.
10) GLP Compliance Auditing
Any non-clinical laboratory facility you use to conduct safety and toxicology testing in animals may be subject to inspection by FDA or other regulatory bodies. Pious Labs can prepare you by performing independent audits of sponsor or contract facilities and studies, giving you additional assurance that a lab is in compliance with regulations (e.g., 21 CFR) and SOPs. Should deficiencies be identified, Pious Labs auditor can recommend remedial actions.
GLP Study Audits
- Review protocol and compliance to protocol
- Review SOP and compliance to procedures
- Perform in-process study inspections
- Conduct data reviews
- Conduct reviews of draft and final reports
GLP Vendor Audits
- Perform routine and qualification audits of contract laboratories
- Inspect facilities and equipment
- Review organization structure and SOP content
- Assess qualification and training of personnel
- Assess testing facilities operation, including test and control articles
- Review records, reports, and record/sample retention
- Assess QA unit
11) Data and Document Auditing
As you know, clear and consistent documents contribute to a faster approval time. Our data and document quality assurance team at Pious Labs is extremely detail-oriented. We can conduct quality audits on your data, reports, and documents, and make sure they are both compliant with applicable regulations and internally consistent. Then you can focus on the bigger picture.
Here are some of the types of data and report we can audit:
- Stability Protocols and Reports
- Annual Product Reports
- Periodic Safety Update Reports
- Non-clinical Study Reports
- Clinical Study Reports
- Investigator Brochures
- Integrated Summaries of Efficacy
- Integrated Summaries of Safety
- SAE narratives
- Analytical data vs. source documentation
- Contributions by various departments
- CMC, non-clinical, and clinical sections for NDAs and ANDAs
Depending on the type of document or data you ask us to review, Pious Labs auditors will:
- Perform internal consistency checks
- Compare text to tables, tables to appendices, appendices to listings, listings to CRFs
- Evaluate compliance with applicable regulations and guidelines
- Compare manufacturing, non-clinical, and clinical overview/summary sections, Investigator Brochures, and integrated clinical summaries for INDs, NDAs, ANDAs, and BLAs to the underlying records, study reports, published references, etc.
- Compare clinical study reports to the protocol, CRFs, data listings, and database
- Assess technical transfer for manufacturing and test methods
- Review submitted method validations