Current Good Manufacturing Practice (cGMP) regulations require all manufacturing processes are clearly defined and controlled. Any changes that have an impact on the quality of the drug are evaluated and validated as necessary. All critical processes are validated to ensure consistency and compliance with specifications. Pharmaceutical companies are keenly aware that they must ensure ongoing compliance with the regulations and be in a state of "inspection-ready" in the event of an inspection from a regulatory body.
Quality Systems
Manufacturers must establish and follow Quality Systems to help ensure that their products consistently meet applicable requirements and specifications. Quality Risk Management is integral to an effective pharmaceutical Quality System. It can provide a proactive approach to identifying, scientifically evaluating and controlling potential risks to quality. It facilitates continual improvement of process performance and product quality throughout the product lifecycle.
MMSTAN INC. offers the following services but not limited to:
Regulatory Audits
MMSTAN INC. designs audit and corrective action plans to accommodate our client's needs, including MHRA, EMEA, and FDA regulations.
We offer the following services but not limited to:
During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company's various systems. MMSTAN INC. then recommends a plan of corrective action, which allows the company to achieve the quality assurance required by the respective regulatory agencies.
A pharmaceutical auditing plan may include corrective actions on:
The elements and steps involved in the audit process may differ depending on the type of audit required and its applied regulatory standards. MMSTAN INC. will work with clients and takes an active role to ensure corrective actions are implemented to remediate the gaps identified during the audit. The goal of having a Quality System is the consistent production of safe and effective products and ensuring that these activities are sustained. A robust Quality System will promote process consistency by integrating effective knowledge-building mechanisms into daily operational decisions.
Pharmaceutical auditing expertise includes writing and review of validation policies, guidelines, site master validation plan and SOP from design qualification to performance qualification steps.
GMP Training
MMSTAN INC. provides cGMP training programs to fit for client needs from cGMP orientation new hires through annual cGMP Training on various cGMP Modules. Our new hire cGMP orientation is an overview of basic GMP concepts and emphasizes, to new employees, the importance of understanding and following government regulations. This will give them a good background to promote regulatory compliance and at the same they will receive on-the-job training.
Equipment Qualification
Process Validation
Computer System Validation
Cleaning Validation
Analytical Method Validation
MMSTAN INC. possess extensive knowledge in various Pharmaceutical manufacturing processes, computerized automated control systems, laboratory instrumentation & information systems, and qualification, validation & audit programs. MMSTAN INC. have qualified staff to assist clients in assessing and defining their compliance and validation requirements for various manufacturing systems and provides the necessary resources to achieve these objectives. MMSTAN INC. qualification and validation services include:
Equipment Qualification
Manufacturing Equipment
Performing IQ/OQ assures that the equipment is installed, operating as intended and therefore enables manufacture of products that meet all quality specifications. Equipment qualification is a US and international regulatory requirement (FDA, MHRA, EMEA, etc.). Installation Qualification (IQ) is a documented evidence that a system or piece of equipment has been installed or assembled to conform to all user requirements, design specifications, and regulatory requirements.
Operation Qualification (OQ) is documented evidence that a system or piece of equipment consistently operates per user requirements, design specifications, and regulatory requirements throughout a specified operating range.
Packaging Equipment
For new equipment, equipment qualification will be complete and approved (IQ/OQ/PQ) prior to initiating the packaging of any lots. Equipment PQ may be conducted as part of the packaging of the commercial validation batches. For legacy equipment that pre-dates the requirements for qualification, the protocol will include a target due date for a retrospective qualification if one has not been completed.
Packaging Performance Qualification is performed to assure that the integrated packaging line equipment and the packaging processes operate within specifications for critical operating parameters and result in packaged product that consistently meets specifications and quality criteria.
Packaging PQ will prove the control and reproducibility of the packaging process on an integrated line for a specific product package configuration. Packaging PQ will be performed on commercial scale lots, packaged following approved procedures and Packaging Production Orders.
Laboratory Analytical Equipment
Laboratory equipment are used in the pharmaceutical industry to acquire data to help ensure that products are suitable for their intended use. An analyst's objective is to consistently obtain reliable and valid data suitable for the intended purpose. Depending on the applications, users validate their procedures, calibrate their instruments, and perform additional instrument checks, such as system suitability tests and analysis of in-process quality control check samples to help ensure that the acquired data are reliable. With the increasing sophistication and automation of analytical instruments, an increasing demand has been placed on users to qualify their instruments.
Analytical instrument qualification (AIQ) is performed using USP General Chapter <1058> Analytical Instrument Qualification. Competing opinions exist regarding instrument qualification and validation procedures and the roles and responsibilities of those who perform them. Consequently, various approaches have been used for instrument qualification, approaches that require varying amounts of resources and generate widely differing amounts of documentation. The qualification process will depend on the complexity and intended use of the instrumentation. This approach emphasizes AIQ's place in the overall process of obtaining reliable data from analytical instruments.
Process Validation
Process validation is defined as establishing documented evidence that a specific process will reliably and consistently produce a product that meets its pre-determined specifications and quality attributes. Processes could encompass manufacturing, filling, sterilization, and packaging within the FDA regulated Pharmaceutical, Nutraceutical, API and Medical Device industries.
Manufacturing Process Validation Services involve a comprehensive and in depth exploration and evaluation of every aspect of the manufacturing environment, including but not limited to:
Computer System Validation
Computer System Validation (CSV) means establishing documented evidence that provides a high degree of assurance that a specific computerized system will consistently operate in accordance with pre-determined specifications. Computer-related system requirements document is the foundation for the computerized system qualification. A successful validation project depends upon proper definition of the system. We can create the following documents and execute the validation protocols for your system.
MMSTAN INC. offers Computer Validation for your Equipment Control System. It can be validated as part of the equipment qualification or as a separate effort but before performing the Process Validation. Our Validation Engineers have many years’ experience in validating Vision Systems, Complex Packaging Systems, Manufacturing Systems including PLC/SCADA/DCS Systems. Provided Validation Support to Continuous Manufacturing Process, which is a new trend in Pharmaceutical Manufacturing arena.
We can train your Validation and Quality Engineers to perform these tasks so that the knowledge can be retained in the organization. Our approach will help your organization to make decisions on how to validate the systems whenever a change is made to an already validated system or when implementing a new system.
Cleaning Validation
The prevention of cross contamination is an essential componentof any GMP program and is necessary to ensure the safety of drugs, biologics and medical devices used in human or veterinary applications. We determine the cleaning processes for each piece of equipment. Ideally, a piece of equipment or system will have one process for cleaning, however this will depend on the products being produced and whether the clean-up occurs between batches of the same product (as in a large campaign) or between batches of different products. When the cleaning process is used only between batches of the same product (or different lots of the same intermediate in a bulk process) the firm need only meet a criteria of, "visibly clean" for the equipment. Such between batch cleaning processes do not require validation.
Analytical Method Validation
Method Validation is defined as the process of providing (thorough Scientific Studies) that an Analytical Method is acceptable for its intended use. Analytical Methods Development and Validation play important roles in the discovery, development and manufacturing of pharmaceuticals. The official test methods that result from these processes are used by QC lab to ensure the identity, purity, potency and performance of drug products.
Our Laboratory Associate Partner Chroma Research Labs Inc. www.chromaresearchlabs.com can provide Analytical Product testing for you Pharmaceutical, Biopharmaceutical, and Medical Device Products. They can also provide Analytical Method Validation services for your products and perform method transfer to your lab.
Commissioning &
Qualification
MMSTAN INC. can provide an efficient, effective documented program that follows and complies with global regulations and guidelines. Our engineering project life cycle experience ensures that commissioning and validation issues impacting on the design phase of a project are fully considered and integrated at the start of a project. We provide consistent guidance for design, construction, and commissioning and qualification of manufacturing facilities. Our qualification efforts will help with sound and responsible interpretation of regulations which govern manufacturing operations. It also reduces the cost of manufacturing pharmaceutical products and medical devices while keeping or improving quality and consistency levels. The Impact Assessments on System Level and Component Level will be used to determine whether the System has to be qualified or commissioned. All systems with direct impact on product quality are qualified and other systems are commissioned. We also make sure that the testing under commissioning will not repeated during qualification efforts and thus we save your time and money.
We can perform C&Q for the following areas but not limited to:
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