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Critical aspects of manufacturing systems are typically functions, features, abilities, and performance or characteristics necessary for the manufacturing process and systems to ensure consistent product quality and patient safety. They should be identified and documented based on scientific product and process understanding. A physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality.

Are planned and systematic reviews of specifications, design, and design development and continuous improvement changes performed as appropriate throughout the life-cycle of the manufacturing system. The design and operation of an equipment or system that is expected to have a direct impact on product quality. Datum or result outside of the expected range; an unfulfilled requirement; may be called non-conformity, defect, deviation, out-of-specification, out-of-limit, out-of-trend.

Any combination of text, graphics, data that can be used to clearly and completely recreate an activity, event or process. Documentation in this procedure shall mean GMP Documents. Means a finished dosage form, for example, tablet, capsule, solution, etc. A legally binding, comprehensive, easy to follow set of instructions, statements and practices to procure materials and workmanship for building, installation and execution of engineering projects.

Mandatory minimum requirements presented in a flexible format fitting the topic, that apply to new construction projects and improvements in design, construction, and testing. Qualification means the process to demonstrate the ability to fulfill specified requirements. Any particulate contaminant with a length at least three times greater than its width.

Good manufacturing practice GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing authorization. Documents generated during a process with the purpose of delivering and proving GMP compliance. A production facility or clinical trial materials pilot plant for the manufacture of pharmaceutical products.

A project where the activities and deliverables are carried out in a GMP environment and have the potential to affect the quality of the products manufactured in the facility. GEP is defined as those established engineering methods and standards that are applied throughout the life cycle to deliver appropriate and effective solutions.

Damage to health, including the damage that can occur from the loss of product quality or availability. Any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. Any material fabricated, compounded, blended, or derived by chemical reaction that is produced for, and used in, the preparation of the drug product. Means labelling derived from a sheet of material on which more than one item of labelling is printed.

It is a document that may undergo revision and re-issuance such as procedure, specification, master record and form. Lifecycle GMP Form is a printed or typed, paper or electronic document, with blank spaces for insertion of required or requested information which, when information is entered, becomes a GMP record.

Includes packaging and labelling operations, testing, and quality control of drug products. Are elements of pharmaceutical and biopharmaceutical manufacturing capability, including facility equipment, process equipment, supporting utilities, associated process monitoring and control systems, and automation systems, that have the potential to affect product quality and patient safety. Means any Type B or Type C medicated feed as defined in Means a Type A medicated article as defined in A deficiency in a characteristic, product specification, process parameter, record, or procedure that renders the quality of a product unacceptable, indeterminate, or not according to specified requirements.

Documented evidence that a complex system of multiple qualified components performs as required, when operated in an integrated manner over the expected range of operating conditions. Action taken to eliminate the cause of a potential discrepancy or other undesirable situation to prevent such an occurrence. Product Realization ISO refers to a set of related processes that are used to bring a product from conceptual to being. Defined as a set of activities planned at the beginning of a project that helps achieve Quality in the Project being executed. An individual detailed document that describes the system under consideration, testing plans, acceptance criteria and test results that ensure that a system is installed and operates in accordance with predetermined specifications.

Proactive and retrospective activities that provide confidence that requirements are fulfilled. The steps taken during the generation of a product or service to ensure that it meets requirements and that the product or service is reproducible. Means any person or organizational element designated by the firm to be responsible for the duties relating to quality control.

Specific measurable activities or processes to meet the intentions and directions as defined in the quality policy. The documented result of quality planning that is disseminated to all relevant levels of the organization. In most cases a Supplier Audit should be performed for custom hardware development.

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Product and Process Understanding 2. Lifecycle approach within QMS 3. Scalable Lifecycle Activities 4. Science Based Quality Risk Management 5. These activities should be defined within the quality management system QMS. This allows for a consistent approach across all systems. There are four major phases defined for any system: 1.

Concept 3. Operation 2.

Acceptance Criteria

Project 4. By conducting this assessment companies can scale their validation effort and other lifecycle activities to the appropriate levels. Figure 2 This model can be expanded or even reduced depending on the scale or scope of the system being validated. This is where a clear understanding of the product and process is critical to determine potential risks to patient safety, product quality, and data integrity.

There should be flexibility regarding acceptable format, structure and documentation practices. Gathering requirements 2. Creation of functional and other specifications 3.

ISPE Glossary of Pharmaceutical and Biotechnology Terminology

System configuration 4. Testing 5. Support 6. Maintenance 7. System retirement It is important to remember that the regulated company has the responsibility for the documentation, approval, and compliance of each element of the computerized system lifecycle. With increased involvement of the supplier in the lifecycle, regulated companies need to assess that the supplier has processes in place to ensure quality of the product. GAMP has included a section in GAMP 5 dedicated to supplier activities to assist suppliers in understanding the needs of their customers.

Effective governance to achieve and maintain GxP compliance. Continuous improvement with in Quality management system QMS. Configurable systems and development models.


Use of existing documentation and knowledge. Monitoring manufacturing, production and storage environments in the pharmaceutical industry. Monitoring the autoclaving process in the pharmaceutical industry. Water purification in the pharmaceutical industry. Freeze drying in the pharmaceutical industryq1 Monitoring manufacturing, production and storage environments in the pharmaceutical industry. Factors such as temperature, humidity, air quality, time and production process characteristics can all have a significant impact on the final quality of a product or batch of products.

For the purposes of traceability, it is necessary to adhere to GAMP 5 guidelines to accurately record every stage in the production lifecycle of a product, encompassing not just the manufacturing process but also the storage and distribution stages. In doing so, manufacturers can prove to have acted in accordance with best practice by building in quality from the outset and designing failure out of the process.

Of the various parameters that need to be carefully controlled, temperature and humidity are perhaps the two most critical All parties involved in the manufacture, storage and distribution of pharmaceutical products are required to record and keep details of temperatures during these processes. Efficient handling and processing of sensitive materials is critical to the profitable manufacture of pharmaceutical products.

GAMP encourages manufacturers to use measurement techniques that allow a better understanding of the interaction between material properties, equipment design and operating conditions, in processes such as capsule forming and drying, pan coating, parenteral manufacturing, sterile filling, spray and powder drying, and tablet compression.

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For many products requiring storage in cool conditions, refrigeration plant is widely used, which needs to be carefully monitored to ensure that the correct temperatures are maintained. Exactly how this is achieved varies according to the type and size of refrigerator being used and the type of product in question. For operators of a storage plant, it is necessary not only to ensure that products are stored at the right temperature, but also that the refrigeration plant is capable of accurately maintaining that temperature.

The resulting temperatures need to be recorded as proof of compliance with the required standards. The requirement to accurately map the storage temperatures also extends beyond refrigeration equipment to include warehouses and controlled temperature rooms.

It is possible to kill some microorganisms with chemicals, irradiation, and dry heat but the most effective and inexpensive method is with saturated steam. The most popular piece of equipment for use in steam sterilization processes is the autoclave. An autoclave is a pressurized vessel that that uses steam to apply pressure and heat to a load placed inside.

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The advantage of using an autoclave is that it can reach temperatures higher than boiling water alone, so it can kill not only bacteria but also bacterial spores, which tend to be resistant. Verification of the process is usually recorded on chartor paperless recorders, though the latter is becoming more widespread. The control functions of an autoclave are normally performed using an integrated control system from the manufacturer. However, it is usual that key parameters are independently recorded against time, including temperature and pressure.

The number of temperature and pressure points that are independently recorded varies by the size of the autoclave to ensure that a representative record is retained.

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  4. Typically three temperature and one pressure signals are used.