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Pengertian dan Jenis-jenis Validasi

Pengertian Validasi

Istilah Validasi pertama kali dicetuskan oleh Dr. Bernard T. Loftus, Direktur Food and Drug Administration (FDA) Amerika Serikat pada akhir tahun 1970-an, sebagai bagian penting dari upaya untuk meningkatkan mutu produk industri farmasi. Hal ini dilatar belakangi adanya berbagai masalah mutu yang timbul pada saat itu yang mana masalah-masalah tersebut tidak terdeteksi dari pengujian rutin yang dilaksanakan oleh industri farmasi yang bersangkutan. Selanjutnya, Validasi juga diadopsi oleh negara-negara yang tergabung dalam Pharmaceutical Inspection Co-operation/Scheme (PIC/S), Uni Eropa (EU) danWorld Health Organization (WHO). Bahkan, Validasi merupakan aspek kritis (substantial aspect) dalam penilaian kualitas industri farmasi yang bersangkutan.

 Validasi diartikan sebagai suatu tindakan pembuktian dengan cara yang sesuai bahwa tiap bahan, proses, prosedur, kegiatan, sistem, perlengkapan atau mekanisme yang digunakan dalam produksi dan pengawasan akan senantiasa mencapai hasil yang diinginkan.

Dari definisi-definisi tersebut tersebut di atas membawa pengertian, bahwa :

• Validasi adalah suatu tindakan pembuktian, artinya validasi merupakan suatu pekerjaan “dokumentasi”.
• Tata cara atau metode pembuktian tersebut harus dengan “cara yang sesuai”, artinya proses pembuktian tersebut ada tata cara atau metodenya, sesuai dengan prosedur yang tercantum dalam CPOB.
• “Obyek” pembuktian adalah tiap-tiap bahan, proses, prosedur, kegiatan, sistem, perlengkapan atau mekanisme yang digunakan dalam produksi dan pengawasan mutu (ruang lingkup).
• Sasaran/target dari pelaksanaan validasi ini adalah bahwa seluruh obyek pengujian tersebut akan senantiasa mencapai hasil yang diinginkan secara terus menerus (konsisten).

Jenis-jenis Validasi

1. Kualifikasi Mesin, Peralatan dan Sarana Penunjang, terdiri dari :

• Design Qualification (DQ)/Kualifikasi Disain (KD)
• Installation Qualification (IQ)/Kualifikasi Instalasi (KI)
• Operational Qualification (OQ)/Kualifikasi Operasional (KO)
• Performance Qualification (PQ)/Kualifikasi Kinerja (KK)

2. Validasi Metode Analisa

3. Validasi Proses Produksi,

4. Validasi Proses Pengemasan

5. Validasi Pembersihan (Cleaning Validation)

Langkah-langkah Pelaksanaan Validasi

Begitu luasnya cakupan validasi, terkadang membingungkan kalangan praktisi di industri farmasi untuk melaksanakan validasi. FDA dalam “Guideline on General Principles of Process Validation”, memberikan panduan langkah-langkah dalam pelaksanaan validasi, yang tertuang dalam “validation life cycle” berikut ini, yaitu :

1. Membentuk Validation Comitee (Komite Validasi), yang bertanggung jawab terhadap pelaksanaan validasi di industri farmasi yang bersangkutan.
2. Menyusun Validation Master Plan (Rencana Induk Validasi), yaitu dokumen yang menguraikan (secara garis besar) pedoman pelaksanaan validasi di industri farmasi yang bersangkutan.
3. Membuat Dokumen Validasi, yaitu protap (prosedur tetap), protokol serta laporan validasi.
4. Pelaksanaan validasi.
5. Melaksanakan Peninjauan Periodik, Change Control dan Validasi ulang (revalidation).

Validation Master Plan (VMP) merupakan dokumen yang menyajikan informasi mengenai program kerja/kegiatan validasi pada industri farmasi yang bersangkutan secara keseluruhan, termasuk jadwal pelaksanaannya.

Dokumen RIV memuat antara lain :

1. Kebijakan validasi.
2. Struktur organisasi kegiatan validasi (komite validasi).
3. Ringkasan fasilitas, sistem, peralatan, dan proses yang akan divalidasi.
4. Format dokumen: format protokol dan laporan validasi, perencanaan dan jadwal pelaksanaan validasi.
5. Pengendalian perubahan.
6. Acuan dokumen yang digunakan.

Contoh “Jadwal Validasi” dalam VMP

http://www.scribd.com/fullscreen/18796812?access_key=key-8uvcz26tq3odryfch0g

Validation

Validation, which includes software validation, is a critical and essential part of your design process, within the Quality Management Systems ISO 13485:2003 and the Risk Management ISO 14971 requirements. Validation is a "must have" part of the Technical Documentation needed for CE Marking or 510 (k) regulatory approval of your medical device. Qserve has in house experts with a great deal of experience, who can support and assist you in complying with these regulatory requirements.

Validation is the sum total of processes required to ensure that a medical device (design) will conform to "user needs" and "intended use(s)", given expected variations in components, materials, manufacturing processes and the use environment.

In general, the validation of a process is the mechanism or system used by the manufacturer to plan,
obtain data, record data, and interpret data. These activities may be considered to fall into four phases

• firstly, an initial qualification of the equipment used and provision of necessary services also known as installation qualification (IQ);
• secondly, a demonstration that the process will produce acceptable results and establishment of limits (worst case) of the process parameters also known as operational qualification (OQ);
• thirdly, an establishment of long term process stability - also known as performance qualification (PQ);
• and lastly, Product Performance Qualification (PPQ), which assures that the product complies to all the safety and performance requirements.

Planning for validation begins early in the design process: performance characteristics that are to be assessed must be identified, and validation methods and acceptance criteria identified.

Qserve Consultancy can assist you with site, process, system and product validations. We can identify the requirements for validation specific to your medical device and related processes, and develop suitable validation study strategies and schemes. Qserve Consultancy can source test facilities and also advise you on the timing of re-validation activities. Our services comprise:

• Identification requirements for validation
• Validation planning: Validation Master Plan (VMP)
• Validation protocols: IQ, OQ & PQ (Installation, Operational & Performance Qualifications)
• Validation tools and techniques
• Monitoring and control
• Validation Gap Analysis
• Re-validation

Examples of the types of validation activity we advise on include:

• Clinical
• Sterilization
• Packaging, labeling
• Shelf-life
• Software
• Clean room

Validation (drug manufacture)
From Wikipedia, the free encyclopedia

History
The concept of validation was first proposed by two Food and Drug Administration (FDA) officials, Ted Byers and Bud Loftus, in the mid 1970’s in order to improve the quality of pharmaceuticals (Agalloco 1995). It was proposed in direct response to several problems in the sterility of large volume parenteral market. The first validation activities were focused on the processes involved in making these products, but quickly spread to associated processes including environmental control, media fill, equipment sanitisation and purified water production. In a guideline on process validation the FDA define (FDA 1987) Validation as: "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes."

Computer System Validation
This requirement has naturally expanded to encompass computer systems used both in the development and production of, and as a part of pharmaceutical products and medical devices, as computer systems have entered more and more into the main stream of drug and medical device production. In 1983 the FDA published a guide to the inspection of Computerised Systems in Pharmaceutical Processing, also known as the ‘bluebook’ (FDA 1983). Recently both the American FDA and the UK MHRA have added sections to the regulations specifically for the use of computer systems, for the MHRA this is Annex 11 of the EU GMP regulations (EMEA 1998), and the FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994 (ISO 1994), which treats “verification” and “validation” as separate and distinct terms. On the other hand, many software engineering journal articles and textbooks use the terms "verification" and "validation" interchangeably, or in some cases refer to software "verification, validation, and testing (VV&T)" as if it is a single concept, with no distinction among the three terms. The General Principles of Software Validation (FDA 2002) defines verification as “Software verification provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase.” It also defines Validation as “Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled”

Goal of Validation
The goal for the regulators is to ensure that quality is built into the system at every step, and not just tested for at the end, as such validation activities will commonly include training on production material and operating procedures, training of people involved and monitoring of the system whilst in production. In general, an entire process is validated; a particular object within that process is verified. The regulations also set out an expectation that the different parts of the production process are well defined and controlled, such that the results of that production will not substantially change over time. This also extends to include the development and implementation as well as the use and maintenance of computer systems. The software validation guideline states: “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes.”

Why Validate
The concept of validation was first developed for equipment and processes and derived from the engineering practices used in delivery of large pieces of equipment that would be manufactured, tested, delivered and accepted according to a contract (Hoffmann et al. 1998). The use of validation spread to other areas of industry after several large-scale problems highlighted the potential risks in the design of products. The most notable is the Therac-25 incident, (Leveson & Turner 1993). Here, the software for a large radiotherapy device was poorly designed and tested In use, several interconnected problems lead to several devices giving doses of radiation several thousands of times higher than intended, which resulted in the death of three patients and several more being permanently injured. Weichel (2004) recently found that over twenty warning letters issued by the FDA to pharmaceutical companies specifically cited problems in Computer System Validation between 1997 and 2001. Validation is intended to provide assurance of the quality of a system or process through a quality methodology for the design, manufacture and use of that system or process, that cannot be found by simple testing alone (McDowall 2005).

Basics
In general the validation process consists of three major phases:
Installation Qualification (IQ) - Demonstrate that the process or equipment to be qualified meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.
Operational Qualification (OQ) - Demonstrate that all facets of the process or equipment are operating correctly.
Performance Qualification (PQ) - Demonstrate that the process or equipment performs as intended in a consistent manner over time.
Although IQ/OQ/PQ are the main phases of the entire validation process, some definitions include other phases such as Design Qualification (DQ).

Scope of Computer Validation
The definition of validation above discusses production of evidence that a system will meet its specification. This definition does not refer to a computer application or a computer system but to a process. The main implications in this are that validation should cover all aspects of the process including the application, any hardware that the application uses, any interfaces to other systems, the users, training and documentation as well as the management of the system and the validation itself after the system is put into use. The PIC/S guideline (PIC/S 2004) defines this as a ‘computer related system’ Much effort is expended within the industry upon validation activities, and several journals are dedicated to both the process and methodology around validation, and the science behind it (Smith 2001;Tracy & Nash 2002;Lucas 2003;Balogh & Corbin 2005).

Risk Based Approach for Computer Systems
In recent years, a risk-based approach has been adopted within the industry, where the testing of computer systems (emphasis on finding problems) is wide-ranging and documented but not heavily evidenced (e.g. 100's of screen prints are not gathered during testing). The subsequent validation or verification of computer systems targets only the "GxP critical" requirements of computer systems, and in this case evidence (e.g. screen prints) is gathered to document the validation exercise. In this way it is assured that systems are thoroughly tested, and that validation and documentation of the "GxP critical" aspects is performed in a risk-based manner optimising effort and ensuring that computer system's fitness for purpose is demonstrated.
The overall risk posed by a computer system is now generally considered to be a function of system complexity, patient/product impact, and pedigree (Configurable-Of-The-Shelf or Custom-written for a certain purpose). A lower risk system should merit a less in-depth specification/testing/validation approach. (e.g. The documentation surrounding a spreadsheet containing a simple but "GxP" critical calculation should not match that of a Chromatography Data System with 20 Instruments)
Determination of a "GxP critical" requirement for a computer system is subjective, and the definition needs to be tailored to the organisation involved. However in general a "GxP" requirement may be considered to be a requirement which leads to the development/configuration of a computer function which has a direct impact on patient safety, the pharmaceutical product being processed, or has been developed/configured to meet a regulatory requirement. In addition if a function has an direct impact on GxP data (security or integrity) it may be considered "GxP critical".

Problems in Validation
Many practitioners within pharmaceutical validation have commented on the increasing requirement for documentation and testing, which does not give extra assurance of the safety or quality of the product. Akers (1993) said: “QA and Regulatory Affairs departments within industry and Regulatory Agencies are obstacles to reduced testing since each group has their own interests to protect. Clearly, reduced auditing and testing and therefore reduced staffing is an unwelcome notion to many middle managers.” And “From the FDA perspective, it has always been safer to have more tests even if they provide no additional statistical confidence in product safety. The result of this has been that even those creative validation people who could have made validation a real process control tool have been thwarted by other special interest groups.” Powell-Evans (1998) said that “…in its Quasi-form, validation is expensive, inefficient, ineffective and awkward. It hinders progress and clogs up otherwise creditable systems for good drug production. GMP now, as we all know, should stand for ‘great mounds of paper’. These mounds are produced in a desperate attempt to ensure that every nook and cranny, every nut and bolt, and every roll and shake of an operators lab coat is signed, sealed and delivered to the regulators cold eye. It should be asked whether all this is necessary and / or beneficial, and whether a better method can be found? Or maybe we should try and understand how validation really works, moreover applied, maybe then we can move away from the Quasi approach industry has adopted, towards the view of those in the know...validation works...if you do it right!!” This has led some practitioners to search for better ways to perform development and validation. This includes moves towards measures of Cost of Quality and Risk Assesement to provide systems that perform the job with enough assurance of quality and safety without the burden of un-necessary documentation and planning (Garston Smith 2001).

Problems of Self Regulation
In general, the regulatory agencies, through laws and guidelines provide a broad overview of what they want pharmaceutical companies to provide, but not how to do it. They will audit the system and list any areas where they feel the approach is not satisfactory, but generally do not provide help on how to fix the situation. This often leads to companies performing more work than is necessary ‘just in case’ or doing less than what is necessary. It is critical that the company has a good understanding of the equipment and the intended use so that the right amount of validation is performed.

Problems in Testing
Testing, metrology, and documentation requirements for validation are challenging. For even relatively simple computer programs, it quickly becomes impossible to test every permutation and route through the program. This was described by Boehm (1970).

Changing Terminology
Given the wide range of the pharmaceutical industry from Research and development to Production, Delivery and Sales and the different regulations like GMP and GLP enacted in different ways in different countries the basic terminology used can be different. This may be solved one day by the International Conferences on Harmonisation (ICH) but until then will be a major problem.

See also
GxP
Good Manufacturing Practice (GMP)
Good Automated Manufacturing Practice (GAMP)
Verification and Validation
Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
Regulation of therapeutic goods
United States Pharmacopeia
IT Pharma Validation Europe Organization: Free Downloads and Information

References
Agalloco, J. (1995), 'Validation: an unconventional review and reinvention', PDA J Pharm Sci Technol., vol. 49, no. 4, pp. 175-179.
Akers, J. (1993), 'Simplifiying and improving Process Validation', Journal of Parenteral Science and Technology, vol. 47, no. 6, pp. 281-284.
ASTM E2537 Guide for Application of Continuous Quality Verification for Pharmaceutical and Biopharmaceutical Manufacturing
Balogh, M. & Corbin, V. (2005), 'Taming the Regulatory Beast: Regulation vs Functionalism', Pharmaceutical Technology Europe, vol. 17, no. 3, pp. 55-58.
Boehm, B. W. (1970), Some information processing implications of air force missions 1970-1980, The Rand Corporation, Santa Monica
EMEA (1998), EUDRALEX Volume 4 - Medicinal Products for Human and Veterinary Use : Good Manufacturing Practice, European Medicines Agency, London
FDA (1983), Guide to Inspection of Computerised Systems (The Blue Book), US Food and Drug Administration, Maryland, USA.
FDA (1987), Guideline on general principles of Process Validation, US Food and Drug Administration, Maryland, USA
FDA (2002), General Principles of Software Validation; Final Guidance for Industry and FDA Staff, US Food and Drug Administration, Maryland, USA
FDA (2004), Part 11: Electronic Records; Electronic Signatures,Code of Federal Regulations, Title 21 - Food and Drugs, Chapter I - Food and Drug administration, Office of the Federal Register, Maryland, USA
Garston Smith, H. (2001), 'Considerations for Improving Software Validation', Journal of Validation Technology, vol. 7, no. 2, pp. 150-157.
Hoffmann, A., Kahny-Simonius, J., Plattner, M., Schmidli-Vckovski, V., & Kronseder, C. (1998), 'Computer system validation: An overview of official requirements and standards', Pharmaceutica Acta Helvetiae, vol. 72, no. 6, pp. 317-325.
ISO (1994), ISO 8402:1994: Quality management and quality assurance -- Vocabulary, International Organization for Standardization, Geneva, Switzerland
Leveson, N. G. & Turner, C. S. (1993), 'An investigation of the Therac-25 accidents', Computer, vol. 26, no. 7, pp. 18-41.
Lucas, I. (2003), 'Testing Times in Computer Validation', Journal of Validation Technology, vol. 9, no. 2, pp. 153-161.
McDowall, R. D. (2005), 'Effective and practical risk management options for computerised system validation', The Quality Assurance Journal, vol. 9, no. 3, pp. 196-227.
PIC/S (2004), Good Practices for Computerised Systems in Regulated "GXP" Environments, Report PI 011-2, Pharmaceutical Inspection Convention, Geneva
Powell-Evans, K. (1998), 'Streamlining Validation', Pharmaceutical Technology Europe, vol. 10, no. 12, pp. 48-52.
Smith, H. G. (2001), 'Considerations for Improving Software Validation, Securing better assurance for less cost', Journal of Validation Technology, vol. 7, no. 2, pp. 150-157.
Tracy, D. S. & Nash, R. A. (2002), 'A Validation Approach for Laboratory Information Management Systems', Journal of Validation Technology, vol. 9, no. 1, pp. 6-14.
Weichel, P. (2004), 'Survey of Published FDA Warning Letters with Comment on Part 11 (21 CFR Part 11)', Journal of Validation Technology, vol. 11, no. 1, pp. 62-66.
Retrieved from "http://en.wikipedia.org/wiki/Validation_(drug_manufacture)"

EasyValid - GPC/SEC System Validation Kit Validation Kit to show GPC/SEC System Suitability and/or Consistent Quality Assurance
PSS has developed a dedicated GPC/SEC System Suitability Test (SST) that evaluates the entire system: equipment, electronics, and analytical operations, and ensures that the integral GPC/SEC system yields "true" Molar Mass determination results. The product is a Quality Assurance Tool for users of Gel Permeation Chromatography (GPC) & Size Exclusion Chromatography (SEC) working in industrial polymer chemistry, research or academic environments, who must provide precise, accurate and reliable information for polymers, plastics, tires, etc. Kit ComponentsThe EasyValid Validation Kit consists of a validation column, calibration standards and certified reference materials with comprehensive documentation; additional WinGPC Unity report layouts and import files are included as an added value for PSS WinGPC Unity Software users.Purchase, 405-0001Span of Applicability EasyValid is specified for validation of GPC/SEC systems equipped with concentration detectors such as RI or UV, independently of brand or model. A typical GPC analytical system would include: Degasser, Pump, Sample injection system, Column oven, Detector(s), Capillaries, Data acquisition hardware, and Data acquisition and evaluation software. Optionally, when the system configuration includes detectors that are sensitive to molar mass instead of concentration, additional reference materials may be needed to compliment the validation kit. PSS manufactures dedicated validation kits for the testing of light scattering detectors, viscometers, Triple, and Triple plus detection systems.Quality Assurance ToolThe EasyValid Validation Kit is ideal for various aspects of quality assurance qualification, whether mandated by stringent requirements (GLP, DIN, ISO 9000x certifications) or good management practices; a few use examples are: System performance check after installationAid for System Operational Qualification/Performance Verification (OQ/PV)Performance, after-maintenance or components replacement Periodical operational verificationInter & intra laboratory consistence checksIdentifying systematic errorsNew employee training evaluation

DESIGN QUALIFICATION (DQ).

DESIGN QUALIFICATION RATIONALE.

Design Qualification is used at the stage where a design that has been developed from the, VMP / URS /GAMP 5 / cGMP / and other Health and Safety Guidelines, is reviewed and documented by competent persons to ensure that the designed equipment, if built, will satisfy all the detailed specified requirements.

I have written before in these documents that certain things are critical, well here we are again. You have taken great trouble to write, and have approved, a URS and a VP (or could be VMP), now a vendor (or could be in house) has come forward and presented a design that they have prepared, and they state it will satisfy your requirements. This is where the majority of major project problems are manufactured, not obvious immediately, but materializing later in the project time line.
The Design Qualification is the only document that is going to confirm that the design will work. It must be carried out by qualified people who can challenge the design performance. If you have no such persons on your staff you must contract them in, or contract the DQ out.
When I arrive on site to manage a project, my very first task is always to get to grip with the design, get all the drawings and review them. I do this because thirty years of experience has made me very aware, that I need to know the design is good. So often this is not the case, and very often there are glaring abnormalities. When these are highlighted with the client and their vendors, only the vendors are smiling. The client had accepted the design and the vendor had quoted for that design, any changes will be extra to the quoted price. Sometimes this has run into seven figures.

A PROPER DESIGN QUALIFICATION IS ESSENTIAL TO YOUR HEALTH.

A DQ can also be used where a company has prepared a User Requirements Specification (URS) for a piece of equipment and is searching for a manufacturer, but is offered equipment Of - The - Shelf. A DG can be used to verify whether the off-the-shelf item will fully deliver the functionality detailed in the URS, and conform to the requirements specified in the VMP / GAMP4 / cGMP and other Health and Safety Notices.

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DQ SCOPE.

The scope of the DQ must include but is not limited to:

• Verification that the design will achieve the URS requirements.
  
• Verification that the design is cGMP, and where software is used , conforms to the life cycle model requested in the VP and detailed in GAMP 4.
  
• Verification that the design complies with the VMP.
  
• Verification that the utility services required are available and validated.
  
• Verification that all the required support documentation is specified.
  
• Verification that the system will be calibratable.
  
• Verification that the system will be maintainable.
  
• Verification of operation staff training requirements.
  
• Verification that the system will operate in a manner safe to both product and staff.
  
• Verification that the system conforms to all applicable national standards and guidelines.
  

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DQ IN THE VALIDATION PROCESS.

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Lemetti, Inc.

Bringing Science to Business™

Independent Technology and Compliance Consultant

Validation Master Plan [DQ/IQ/OQ/PQ:

Validation can be applied to a single chamber or to an entire facility. We provide guidance starting from the start, write necessary documentation, execute the protocol and write the final report. The following provides a more amplified version of validation as it relates to equipment or facility. Master Validation Plan (MVP) for a facility is composed of the following.

Design Qualification (DQ)

Design aspects of equipment/facility is documented, checked and approved. The DQ contains descriptions and shows that the equipment/facility design agrees with the design specifications of the customer. Design aspects defined must be listed and evaluated with respect to their influence on product quality.

Design is checked to ensure that applicable codes of federal regulations are fulfilled and compliance to good manufacturing practices is documented. In the definition of the DQ, qualified personnel from various departments of the company should be involved. The involvement is important in the DQ for the identification and definition of which must be performed later phases.

DQ demanded by the customer are compared with the actual design of the equipment/facility. Written evidence of this comparison is produced. Once DQ is approved, the status of the DQ is frozen and the DQ and the specifications are now under the control of change management.

Installation Qualification (IQ)

IQ provides written evidence is supplied that all equipment in the facility are installed according to the equipment supplier(s) and purchase specifications. For complicated or large pieces of equipment, it is possible to undertake a pre-delivery check of the equipment at the supplier’s assembly facility. It is documented that the operating criteria for the equipment, as installed, are in compliance with the P&I diagrams, facility functional specifications, and process flow diagrams.

The IQ represents the status of the equipment/facility where the completeness and correctness of all required documents are confirmed. IQ refers as often as possible to engineering documents, such as P&I diagrams, functional specifications, process flow diagrams, and inventory lists to reduce documentation.

An auditor and a witness carry out the test procedures given in the approved IQ protocols. During the test procedures, the auditor will decide whether or not the test acceptance criterion is/are fulfilled. A witness certifies by signature that the test procedures are carried out by the auditor in accordance with their test specifications. Results of the test procedures become the IQ report.

Operational Qualification (OQ)

OQ provides documented evidence is given that all parts of the equipment/facility work within their specifications and process parameters are within the acceptance criteria.

Standard operating procedures (SOPs), maintenance, calibration, and cleaning should be developed during the OQ process, including maintenance and calibration schedules. Each OQ document contains a list of required SOPs for the use of a piece of equipment in the facility. Training of staff should take place and be documented. Calibrations of measuring and controlling devices are confirmed. Start-up protocols and engineering documents refer as often as possible to engineering documents, such as P&I diagrams, plant functional specifications, process flow diagrams, and inventory lists to minimize documentation; like in IQ.

The test procedures are carried out by an auditor and a witness. During test procedures, the auditor will decide whether or not the tests acceptance criteria are fulfilled. The witness certifies by signature that the test procedures are carried out by the auditor in accordance with their test specifications. The OQ protocols are filled in with all results of the test procedures and become the OQ report. The OQ reports will be approved by responsible persons.

Performance Qualification (PQ)

PQ provides documented evidence that all parts of the facility and the processes validated produce products of the specified quality under conditions of normal production. It is shown that product quality is within the specifications as long as the quality of raw materials stays within specification. The PQ includes critical variable studies, for example, by simulating conditions of upper and lower processing, processing at the operating limits of the equipment, or cir­cumstances like worst‑case conditions. It is shown that such conditions should not necessarily induce process or product failure.

PQ qualifies the entire facility with respect to production. All necessary protocols should be approved. Values of critical and non-critical process parameters recorded during PQ must be collected to evaluate the efficiency and performance of the equipment/facility.