Services
Pharmaceutical Qualification Services Computerized Systems Validation Plant Upgradation Third Party (3P) Auditing Inspection Readiness GMP Training Programme
We offer an extensive array of consulting services to set up Quality Systems for drug development, scale-up, technology transfer, commercialization, and post-inspection responses and remediation. This encompasses various sectors of the industry.
- Setting-up effective Quality Systems suitable to the size and complexity of the processes and operations.
- Harmonization of SOPs /policies / procedures including Quality Plan, Validation Master Plan and Site Master Plan for the operations.
- Facility Assessment to identify gaps and opportunity for improvement in processes / systems.
- Prepare Equipment Qualification Master Protocol, Execution checklist and compilation of Qualification summary reports.
- Provide Process Validation and Cleaning Validation guidance and related documentation.
- Preparing for an inspection to face regulatory audits including Mock-inspection, SMEs and documents readiness, and follow- up for the compliance.
- Quality Risk Management(QRM) and Quality investigation for Market complaints and Manufacturing deviations.
- Supplier qualifications including Due diligence, site audits and periodic evaluations for APIs, Excipients, Primary. packaging materials and contract service providers.
- Third-party release of batches through monitoring of batch processing including review of batch records and laboratory records.
- Quality Supports to define strategy for decommissioning and relocation of the Equipment/ Facility.
- Quality systems integration during merger / acquisition of new firm.
- Prepare response for Regulatory Inspection and Remediation Planning.
- Pharmaceutical Facility Qualification Services for starting up new facilities and expanding existing production capacity as required.
- Provide On-site and Virtual GMP training on various topics as required by the companies.
Pharmaceutical Qualification Services
Our consultants in pharmaceutical facility management have vast experience in the commissioning and qualification of facilities, utilities, and process equipment for a range of pharmaceutical products, including APIs, solid dosage forms, and sterile injectables. Their expertise ensures a safe and smooth initiation of new facilities and modifications to existing ones.
To assist our clients’ engineering and quality functions, we prepare crucial commissioning and validation documents in accordance with current engineering best practices. The documents we produce include:
- Facility Qualification.
- HVAC Qualification.
- Equipment Qualification.
- Utility Qualification (WFI, RO/DI/Purified Water, Pure/Clean Steam, Clean Compressed Air, Nitrogen, etc.).
- Personnel Qualification for Aseptic area operations.
Computerized Systems Validation (CSV)
The pharmaceutical industry recognizes the significance of validated computer systems, such as automated and process control systems, laboratory information management systems, document management systems, and Learning Management Systems, for essential operations and manufacturing.
Catalyst experts acknowledge the varying validation levels needed for each system, contingent upon its specific risk and influence on patient safety, product quality, and data accuracy. Our team assists in creating procedures, processes, and templates for Computer System Validation, streamlining costs and ensuring compliance with regulations.
Integrated Quality System and its Implementation
Pharmaceutical manufacturers, often adjusting their business strategies or undergoing mergers and acquisitions, may face the challenge of integrating a new company with a distinct quality system into the parent company’s processes. This integration is vital for consistent quality and business risk evaluation by management. Without proper integration, there’s potential for incorrect risk assessments under dual systems, which can result in flawed decisions and compliance issues.
The assessment pinpoints which quality subsystems are readily integrable. For instance, training the new company on the parent’s policies or granting them access to online tools of the parent company. The assessment also highlights areas needing thorough review and possible rectification. An instance is the transition from paper records to a digital system, where the online format might demand data not previously required in the paper version.
Plant Upgradation
If your company aims to obtain approval from a strict regulatory body (such as USFDA, EMEA, MHRA, TGA, etc.) and already has local regulatory approval, you might consider the Plant Up-gradation Service. Included in Plant Up-gradation services are:
- Establishment of Proper scope for which regulatory is being targeted.
- Gap Assessment of Existing Plant.
- Preparation of CAPA Plan Changes in Layout and design.
- Qualification / Requalification Validation /Re-Validation.
- Policies and Procedures revision.
- Training.
- Establishment/restructuring of Internal Audit System.
Third Party (3P) Auditing
Catalyst offers support for your company’s GMP audit requirements through our certified GMP auditors for both internal and external audits. Our auditors possess extensive hands-on auditing experience and comprehensive knowledge of regulations such as WHO-GMP, USFDA, MHRA, EMEA, etc. They are adept at conducting third-party audits for manufacturers of Drug Products, Active Pharmaceutical Ingredients, Medical Devices, Dietary Supplements, Raw Materials, Excipients and Packaging Materials.
Inspection Readiness
Catalyst provides advice on crafting an SME training strategy, covering the selection of top candidates, evaluating weaknesses and strengths, grasping typical FDA inquiry methods, and gauging readiness through mock inspection interviews.
When FDA inspectors are at your threshold, are you geared up? While you might first consider logistics, venue, document accessibility, and your facility’s state, have you thought about your staff? Are they equipped to engage with FDA experts trained meticulously in probing manufacturers’ processes?
Training for SMEs—and indeed, any staff partaking in inspections—should encompass more than just company rules, protocols, SOPs, and federal guidelines. Training should instill knowledge of inspection decorum, communication skills, the strategies inspectors adopt to gather data, potential questions they might pose, and effective response strategies.
FDA 483 and Warning Letters Remediation Services
Catalyst assists pharmaceutical firms in crafting responses to the FDA following the receipt of a Form 483 or Warning Letter. It’s crucial that your feedback to the FDA is prompt, precise, and outlines the corrective/preventive steps you plan to take.
Receiving FDA 483s or Warning Letters demands immediate attention. Companies should promptly address the noted concerns, as well as any related issues not specifically cited, and convey these actions to the FDA.
Furthermore, Catalyst offers its services as an independent party for inspecting, assessing, and evaluating facilities and records. We can develop a plan of correction and response aligned with FDA guidelines.
Data Integrity Auditing Program
The Catalyst Consulting team carries out comprehensive Data Integrity assessments and Forensic audits, offering remediation suggestions. We examine all facets of your company’s record-keeping and data storage procedures for batch processing and laboratory systems, encompassing the services listed below.
- Development of data integrity programs, policies, and procedures.
- Data Integrity Training and Assessments.
- Data Integrity Assessments for both electronic and paper records.
- Forensic audit of data generated for projects/products.
GMP Training Programme
We provide both online and in-person training on diverse GMP topics to enhance your team’s capabilities whenever and wherever needed. Our course content is crafted alongside subject matter experts. Additionally, we assist with sector-specific training needs and the development of soft skills.