Introduction to Qualification, Validation and Mapping
Numerous regulations must be followed to operate a business, but they all have the same concept on one subject. If you work with pharmaceutical, food, and beverage products and want to meet GMP/GDP guidelines, ISO1514 & ISO22000 standards, you must qualify the suitability of your facilities, which includes production, product handling, storage, and transportation.
What is Validation?
According to GMP/GDP guidelines, validation ensures that the process or activity produces the expected result and outcome. In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) stated that all quality-relevant methods must be validated to maintain high quality and the integrity of distribution processes.
The first step in validation is to define the expected results, and the second is to verify and document that the process produces the desired results. For example, suppose you are storing pharmaceutical products in a warehouse. In that case, you will require qualified personnel to perform the SOP and specific equipment to ensure the goods are correctly stored. All of the above should be taken into account when performing validation.
What is Qualification?
According to GMP/GDP guidelines, qualification is the process of proving that the facility, system, supplier, and room fulfil the intended purpose. In a nutshell, if the equipment is used to manufacture, handle, store, or transport pharmaceutical or food and beverage products, a qualification must demonstrate that the equipment is fit.
For example, if the fridge must maintain a temperature range of 2°C to 8°C, the qualification is to certify that the fridge consistently keeps the temperature range of 2°C to 8°C. As a result, stuff always begins with the intended purpose and ends with evaluation and documentation.
To support GMP/GDP validation and qualification, we provide Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services in accordance with GMP/GDP guidelines.
What is Temperature & Humidity Mapping?
Temperature & humidity mapping is the measurement and documentation of the temperature distribution within a specific area to identify the high fluctuation, hottest and coldest locations. According to the World Health Organization (WHO) guidelines, mapping is also used to identify areas requiring corrective action.
A temperature mapping study is conducted over some time, typically a few days or weeks. As per WHO guidelines, it monitors the temperature and humidity in various locations within a particular area, such as a refrigerator, warehouse, room, box, or container.
By preparing a mapping plan, calibrated data loggers are clearly labelled, configured, and placed at the predetermined mapping points. After the specified period, all data loggers are retrieved and analysed to determine the room’s high fluctuation, hottest and coldest spots. It is recommended to install Temperature & Humidity Sensors in the high fluctuation, hottest and coldest places, as a temperature excursion at these locations would have the most significant impact and therefore be measured first.
Retort & Autoclaves Thermal validation and Qualification In the Pharmaceutical (IQ/OQ/PQ) & Food Processing industries.
What is Thermal Validation?
The purpose of thermal processes applied to heat-preserved foods in industries is to eliminate all organisms capable of growth during subsequent storage. Thermal validation is obtaining scientific and technical evidence to ensure that the thermal process applied is sufficient and correct so that the selected control retort temperature & holding time can effectively control the target organisms.
High-pressure saturated steam is used in the pharmaceutical, healthcare, and medical device industries for steam sterilisation, which kill microbes on medical device surfaces by a thermal process. An autoclave is a pressurised chamber in which medical devices will continuously be exposed to 121 °C steam for a predetermined amount of time to effectively kill the microbes on the surface of medical devices.
Thermal validation is crucial to the food safety standard compliance of HACCP & ISO22000 plans, and the validation report is frequently requested by auditors (US-FDA, HACCP & ISO22000) and customers. Thermal validation must adhere to stringent criteria, and it is advantageous to have the validation performed by third-party experts with relevant experience and impartiality regarding the products and processes. A third-party validation firm will bring fresh eyes to the process and be better equipped to challenge it. This is especially true during the setup phase of a new product’s heat process or during the commissioning phase of a new retort.
To comply with WHO, FDA, and NPRA, pharmaceutical industries must validate their autoclaves. Thermal validation of the autoclave is one of the most important processes for sterilising medical devices, products, products in sealed containers or packages, and tools used in the testing or production of Pharmaceutical and Medical Device products. The Autoclave Validation procedure ensures that all microorganisms are effectively eliminated.
Thermal Validation Process
1
Heat Distribution Studies
Temperature distribution studies are temperature mapping that measures temperature uniformity in retort or autoclaves to identify the cold area or the slowest heating area and ensure that the thermal process temperature and holding time criteria have been met.
These studies must be carried out with sufficient temperature dataloggers and well distributed inside the retort or autoclaves.
2
Cold Spot Identification
Once the area with the lowest heating level has been identified, the temperature dataloggers should focus on locating cold spots in that region. It comprehends a process’s “worst-case” variables, and the Heat Penetration test focuses solely on cold spots. Cold spots identification is finding the location of the slowest heat penetration within a product.
This is because the rates of heat transfer change depending not only on the type of product (thin, thick and contents) but also on the type of packaging (size, material, and shape). As a result, the positions of these cold spots will depend on the type of product & packaging. Generally, cold spots for products only can be identified through experiments.
3
Heat Penetration Studies
The Heat Penetration Tests that are performed during the validation process ought to be designed in such a way as to simulate the “worst-case scenario” of heating conditions. This ensures that there will always be an absolute minimum level of heat treatment applied during average production. When conducting heat penetration studies, one should typically use a product representative of the slowest heating properties.
4
Compliance with FDA’s 21 CFR 11
The validation datalogger and software used in the validation process must comply with FDA 21 CFR 11, which governs electronic records and electronic signatures. We use the guidelines to validate the retort/control system and ensure that it meets all Part 11 requirements, such as user security/access, change control and audit trails, and data integrity.