• Facility (Area or Room) Qualification
• Utilities (Purified Water system, Water For Injection (WFI), Pure Steam, HVAC system, Compressed air system) Qualification
• Equipment (Production, Packing and Laboratory) Qualification
• Packaging Validation
• Cleaning Validation
• Computer systems Validation
• Process Validation

Facility Qualification

Facility Qualification validates the overall manufacturing, testing and the production environment. The requirement is as usual driven from the product processes. Where the product process requires specific room conditions, the engineers must design the respective Area or Room to enable these conditions to be achieved and maintained. Good Engineering Practices (GEP) must be used to protect these conditions as required, using the appropriate quality of air filtration, temperature, humidity, airflows and differential pressure controls. At MN Validation Solutions (MNVS) we offer the following services on Facility Qualification in accordance with current Good Manufacturing practices:

• Qualification of newly constructed production rooms or areas (Production, Packing and Laboratory).
• Qualification of temperature-controlled areas (Cold Rooms, Capsule Storage room, Warehouses, Broken Bulk stores and Flammable stores).
• Requalification of modified rooms or areas.

Utilities Qualification

Pharmaceutical products are highly regulated and given the stress on product quality and the widespread impact of substandard production on health and safety products, Utilities Qualification is critical a critical step pharmaceutical companies should take towards ensuring that all products they manufacture comply with the guidelines and current Good Manufacturing Practices (cGMP). At MN Validation Solutions (MNVS) we offer the following services on Utilities Qualification in accordance with current Good Manufacturing practices:

• Qualification of Water systems (RO, Potable, Purified Water, Water for Injection, Pure Steam) and Annual Periodic reviews.
• Qualification of HVAC (Re-circulating, Once through & Ventilation evaporative) systems and Annual Requalifications. Re-circulating HVAC system
• Qualification of Compressed Air systems (IQ, OQ and PQ) and Annual Requalifications.

Equipment Qualification

Equipment Qualification is the final series of inspections and test to ensure that all requirements are met as per the User Requirement Specifications (URS). At MN Validation Solutions (MNVS) we offer the following services on Equipment Qualification in accordance with current Good Manufacturing practices:

• Design Qualification – Documenting manufacturer’s specifications and any other specifications that the user may have. The goal is to make sure that the customer received the right equipment with the correct specifications.
• Installation Qualification – Documenting that the equipment has been installed according to manufacturer’s recommendation. The goal is to ensure that all parts are available and that they are all set up correctly.
• Operation Qualification – Verifying that the equipment can meet the analytical specifications required for it to operate. This process involves running a series of operational checks to demonstrate that the equipment meets the specifications stated in the Design Qualification (DQ). The goal is to ensure that the equipment operates as intended.
• Performance Qualification – Verifying that the equipment performs as intended (in some cases, using a product) with the assistance of the supplier. The goal is to ensure that the equipment meets all the performance parameters as specified in the Design Qualification (DQ).

Packaging Validation

Packaging Validation is a total process involving the identification and control of packaging materials and packing equipment that affect the ability of a packed product to meet its acceptance requirements. At MN Validation Solutions (MNVS) we offer the following services on Packaging Validation in accordance with current Good Manufacturing practices:

• Gap analysis – Document and Desktop study prior to the commencement of the Packaging Validation project.
• Compilation of the Packaging Validation Master Plan – includes Product matrices, Bracketed product groups and Packaging Validation project timelines.
• Compilation of the Packaging Validation SOP – outlines Packing Validation procedure and number of packing processes to be validated.
• Compilation of the Packaging Line Performance Qualification (PQ) protocol – PQ to be performed on all equipment on that specific Packing Line.
• Execution of the Packaging Line PQ protocol – one batch sufficient for establishing optimal PQ setting for each equipment.
• Compilation of the PQ Summary Report – summary of all results obtained during the execution of the PQ protocol.
• Compilation of the Packaging Validation (PV) protocol
• Execution of the PV protocol – number of batches used to be determined using a risk-based approach.
• Compilation of the PV report – summary of all results obtained during the execution of the Packaging Validation protocol.

Cleaning Validation

Cleaning Validation is the process of assuring that cleaning procedures effectively remove the residue from manufacturing equipment/facilities below a predetermined level. The main purpose of validating a cleaning process is to ensure compliance with standards regulations and the identification and correction of potential problems previously unsuspected, which could compromise the safety, efficacy or quality of subsequent batches of dry product produced within an equipment. At MN Validation Solutions (MNVS) we offer the following services on Cleaning Validation in accordance with current Good Manufacturing practices:

• Gap analysis – Document and Desktop study prior to the commencement of the Cleaning Validation project.
• Compilation of the Cleaning Validation Master Plan – includes Cleaning Validation approach, Matrixing of equipment chains and Cleaning Validation project timelines.
• Compilation of the Cleaning Validation SOP – outlines Cleaning Validation procedure and number of cleaning processes equipment chains) to be validated. Worst-case approach (toxicity, potency, solubility and difficulty to clean) to be used when selecting the product used for Cleaning Validation studies.
• Compilation of Cleaning Validation protocols
• Compilation of Cleaning Validation reports

Process Validation

Process Validation is the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products. Process Validation is a requirement of current Good Manufacturing Practices (cGMP) for finished pharmaceuticals (21CFR 211) and of the GMP regulations for medical devices (21 CFR 820) and therefore applies to the manufacture of both drug products and medical devices. At MN Validation Solutions (MNVS) we offer the following services on Process Validation in accordance with current Good Manufacturing practices:

• Process design – process definition based on knowledge gained through development and scale-up activities.
• Process Qualification – confirmation of the process design being capable of reproducible commercial manufacturing.
• Continued Process Verification – Ongoing verification during routine production to ensure that the process remains in a state of control.
• Prospective Validation – involves validation of the process of a new formula (or within a new facility) prior to routine production.
• Retrospective Validation – involves validation of facilities, processes and process controls that have not undergone a formally documented validation process. Validation is possible using historical data.
• Concurrent Validation – involves establishing documented evidence that a facility and processes do what they purport to do, based on information generated during the actual imputation of the process. It also involves monitoring critical processing steps and final product testing to show that the manufacturing process is in a state of control.
• Revalidation – involves repeating the original validation effort and investigative review of the existing performance data. This approach is essential to maintain the validated status of the plant, equipment, manufacturing processes and computer systems. Reasons for revalidating the process include:
  1. Transfer of product from one manufacturing plant to another.
  2. Changes to the product, the plant, manufacturing process, cleaning process and other changes that could affect product quality.
  3. Necessity of periodic checking of the validation results.
  4. Significant increase or decrease in batch size.
  5. Sequential batches that fail to meet product specifications.

QUALITY SYSTEM (QS)

In conducting product process improvement, MN Validation Solutions (MNVS) has identified Quality Systems as a major tool in process improvement in the pharmaceutical industry. At MN Validation Solutions (MNVS) we understand the challenges encountered in pharmaceutical industry in product process improvement with respect to the application of quality systems. We have intensely studied the five subsystems above and established that they are vital in each manufacturing facility and are all inter-dependent so as to guarantee product quality is not compromised. As MNVS we study each of these subsystems in your industry and ensure we assist your organization in improving processes by developing systems and implementing procedures that will be effective in the organization. Our aim is to develop strong quality systems and guided process improvement that will:

1. Improve product and process understanding.
2. Minimize product variability.
3. Enhance test method accuracy.
4. Reduce costs due to few product investigations.
5. Reduce deviations and product rejections.

After having designed and modelled an efficient quality system, our systems will ensure compliance with GMP/GLP by warranting that the following are effective:

1. Quality management.
2. Quality Assurance.
3. Risk management.
4. Preventative action.
5. Continuous improvement.
6. Evaluation analysis and risk management tools.

At MN Validation Solutions (MNVS) we have a comprehensive understanding of organizational structure, responsibilities, procedures, processes, data management, resources, customer satisfaction and continuous improvement; and these are key elements of an effective QMS. After an intense analysis of an organization on the elements previously mentioned, we design efficient systems that will result in:

1. Increased customer loyalty.
2. Increased market share value.
3. Improved operational efficiencies.
4. Cost reductions.
5. Effective and efficient use of resources.
6. Competitive advantage.
7. Flexibility and ability to respond to market opportunities
8. Control on all processes.

It should be noted that quality systems discussed above are also an important component of QMS. Without neglecting other QMS areas, we have identified the following as important components of QMS. Our QMS furthermore covers the following areas:

1. Documentation control

   Due to the complexity of the pharmaceutical industry, we assist companies to deal with QMS related to Validation and Compliance. In the pharmaceutical industry, documentation is used daily and thus it necessary to have documents backing up any form of non-compliance.

2. CAPA and Deviation management

   Our expertise is to look at the trends of your organization, consequently developing corrective action and preventative actions encountered in your organization by conducting intensive root cause analysis (RCA), root cause investigation (RCI) and quality risk assessments (QRA).

3. Initiation of change controls related to Good Manufacturing Practices
4. Compilation and Updating of Site SOPs.
5. Training programs to personnel on GMP and Validation.
6. Preparing manufacturers for Regulatory audits.
7. Preparing Warehouses and distribution facilities for audits.

1. Plant design
2. cGMP accreditation assistance and Audit Preparation support (WHO/SAHPRA/FDA)
3. Validation services (Production/Laboratory equipment; Utilities, Process Validation, Cleaning Validation, Packaging Validation, Temperature mapping, Facility Qualification)
4. Quality Assurance and Quality Management System (Deviations, Change controls, CAPAs, Failure Investigation, Customer complaints trending, SOPs)
5. Training
6. Project assistance in Plant/Facility upgrades.

1. Validation services (Production/Laboratory equipment; HVAC, RO Water System, Process Validation, Cleaning Validation, Packaging Validation, Temperature mapping, Facility Qualification)
2. Process optimization
3. Quality Assurance, Quality Management System, Site Master Files, Quality Risk Management, Audit Preparation Support, Standard Operating Procedures (SOP’s), Quality Manual, Training, Vendor evaluations and Technical Quality Agreements.
4. Master Maintenance Plans and Service Level Agreements (SLAs)