The equipment qualification process in pharmaceutical industry has four stages, design, installation, operational, and performance qualification. Installation qualification is the second stage of the pharmaceutical equipment qualification process. It lays the foundation of the qualification process by ensuring proper installation of the equipment. This is critical for the success of operational qualification and performance qualification stages. The proper functioning and performance of pharmaceutical equipment depends on the installation qualification process. Hence, installation qualification in pharmaceutical industry helps determine proper installation of all equipment, thereby ensuring their proper operation.
What is installation qualification in pharmaceutical industry?
Installation qualification (IQ) ensures pharmaceutical equipment, systems, or instruments are installed properly according to the manufacturer’s specifications and meet predefined requirements. The aim of installation qualification in pharmaceutical industry is to verify and document proper equipment installation to prepare for the subsequent stages of the equipment qualification process. Moreover, all pharma equipment should be installed by trained personnel as per drawings and specifications provided by the manufacturer or supplier. Furthermore, an approved protocol formulated by the design and engineering department should be used to perform the installation qualification phase. Notably, IQ is a part of GMP requirements and most regulatory authorities require pharma companies to conduct thorough IQ. Moreover, IQ has a role in ensuring the pharmaceutical products produced are of consistent quality.
Practical examples of conducting IQ in pharma industry: While conducting IQ for a chromatography system, whether all tubing, flow meters, and detectors are installed correctly is verified. Additionally, whether the equipment matches layout diagrams is checked. On the other hand, while performing IQ for an autoclave system, whether proper connections for electricity, water, and steam has been made is checked. Whether all components are installed properly and the autoclave is placed in the sterilization room as per environmental requirements is verified.
IQ protocol and necessary documentation
Installation qualification should be performed per an IQ protocol formulated and approved by the design and engineering department. Furthermore, a detailed IQ checklist should be referred to while carrying out the IQ process.
IQ protocol: A detailed IQ protocol has to be developed. It should include the following:
- Methodology, scope, and criteria for conducing the equipment installation qualification.
- An installation criteria checklist for reference
- Equipment identification details, such as the model, serial number, and manufacturer
- Installation requirements and process according to the manufacturer’s or supplier’s specifications
- Environmental requirements, such a necessary temperature and humidity
- Full list of equipment as well as systems that have to be qualified
Installation checklist: The IQ protocol requires the preparation of a detailed installation checklist. It must cover all aspects, including physical and software installations, electrical connections, and calibration, of the installation process.
Preparation of an IQ report: A report documenting how the IQ protocol was executed has to be prepared. It should clearly state whether the pharma equipment installation satisfies the predefined criteria. Furthermore, the IQ report should include a summary of the findings.
Importance of installation qualification in pharmaceutical industry
- Equipment installation error prevention: Installation qualification helps identify and address equipment installation errors early on. Resolving these issues at early stages can prevent costly operational failures or help avoid threat to product quality.
- Quality assurance: Properly installed equipment ensures the manufacturing process runs smoothly and consistently. This is vital for producing high-quality pharmaceutical products that meet safety benchmarks.
- Regulatory compliance: Conducting installation qualification in pharmaceutical industry is a key requirement of most regulatory authorities. IQ ensures the equipment installation aligns with strict pharmaceutical standards, thereby reducing the risk of regulatory non-compliance.
- Equipment installation traceability: Documentation and record keeping is a vital requirement of the IQ process. These documents are required to clearly record the equipment installation process. This is critical for audits, inspections, and troubleshooting, thus IQ is vital for traceability.
8 key steps of the pharmaceutical installation qualification process
Installation qualification is a critical component of the pharmaceutical equipment qualification process. IQ ensures the pharma equipment and ancillary systems are installed correctly according to the specifications provided by the manufacturer. We have provided an overview of the equipment installation qualification process.
- Preparation of IQ protocol: A detailed IQ protocol has to be created. It should mention all the tests and checks to be performed as well as the scope, objectives, responsibilities, and acceptance criteria for the IQ process. Furthermore, it should detail the equipment descriptions, installation procedures, and necessary documentation.
- Equipment description and identification: All relevant information, including manufacturer details, model number, serial number, about the equipment has to be documented. This equipment information has to be checked with the purchase order and design specifications.
- Verification of equipment installation: Check whether the equipment installation site satisfies all specified requirements, such as environmental conditions, structural support, space, and utility connections. Additionally, verify whether the equipment has been installed in the correct location. Furthermore, ensure all utilities, such as electrical supply, water, and HVAC systems are connected, functional, and meet specifications. Finally, ensure proper assembly and mounting of all equipment components as per design plans.
- Component and system verification: Inspect the equipment’s components and parts to ensure all parts are present and installed correctly. Additionally, they should match design specifications. Validate the equipment has been assembled per the manufacturer’s guidelines.
- IQ documentation review: Check whether critical documents, such as user manuals, calibration certificates, SOPs, and training records, are present. Additionally, validate part numbers, serial numbers, and labels against equipment design specifications. Moreover, verify that installation drawings and wiring diagrams are accurate.
- Test equipment functionality: Verify whether the equipment functions as intended under normal installation conditions as well as complies with regulatory guidelines and company standards. Moreover, perform tests on safety features, alarms, and control systems to ensure they are properly operating.
- Record any deviations and corrective actions implemented: Identify and document any deviations or equipment installation discrepancies. Moreover, implement corrective actions to resolve issues and mitigate future recurrence.
- Preparation of a detailed IQ report: The entire installation qualification process has to be properly documented. Record all test results, observations, deviations, and corrective actions in a comprehensive IQ report. Finally, the IQ report has to be vetted by qualified personnel, such as engineers and quality assurance representatives.
Thus, these installation qualification steps ensure the pharma equipment is installed properly. Furthermore, they lay the foundation for next phases of the equipment qualification process.
Common challenges faced during the installation qualification phase
- Equipment not abiding by the predefined design or regulatory specifications may require modifications or replacements.
- Inadequate utility connections, such as power, water, or air supply, or unsuitable environmental conditions, such as temperature or humidity, can hinder proper equipment installation.
- Poor communication among various departments, such as engineering, quality assurance, and vendors, may lead to delays or errors in installation qualification in pharmaceutical industry.
- Missing or inaccurate documentation can delay the IQ process.
- Ensuring compliance with stringent regulatory guidelines for pharma equipment can be challenging. Moreover, if the equipment is complex or involves new technologies, it will face further regulatory scrutiny.
- Absence of trained personnel and necessary tools will impact the effectiveness and efficiency of the IQ process.
- Unexpected deviations during equipment installation, such as incorrect assembly or missing components, will require corrective actions. This will be time-consuming and impact the IQ phase.
Therefore, performing installation qualification in pharmaceutical industry can be challenging and cumbersome. To address these challenges, meticulous planning, effective communication, and adherence to GMP guidelines will be necessary. Effective and thorough installation qualification has to be carried out for successful equipment qualification. Pharmaceutical industry is stringently regulated and most regulatory bodes require pharma companies to perform effective equipment qualification. To achieve regulatory excellence, email at [email protected] or call/Whatsapp on 9996859227.
