Roorkee College Of Pharmacy, Roorkee, Uttarakhand
Validation is a critical component of pharmaceutical quality assurance, mandated by Good Manufacturing Practices (GMP) and regulatory guidelines including Indian Pharmacopoeia (IP) 2022. Stability chambers and pharmaceutsical water systems represent essential infrastructure requiring stringent validation to ensure product safety, efficacy, and regulatory compliance. This study aims to generate comprehensive validation data for pharmaceutical purified water systems and stability chambers in accordance with IP 2022, WHO Technical Report Series, and ICH Q1A(R2) guidelines. The goal is to confirm that these systems consistently operate within predefined parameters, ensuring the quality of drug products throughout their lifecycle. A phase-wise, experimental validation design was implemented, involving Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) stages. For purified water systems, validation was conducted in three phases over a year, incorporating physicochemical and microbiological testing. Stability chamber validation included 3D thermal and humidity mapping across ICH zones (I to IVB and accelerated) using calibrated Electronic Data Logging M.
The paramount and well recognized cGMP criteria is the validation of pharmaceutical processes. The quality system (QS) rule mandates the need for process validation. The objective of a quality system is to consistently manufacture products that are appropriate for their intended use. Process validation is an essential element in guaranteeing the fulfillment of these principles and goals [1]. In 1970, members of the Food and Drug Administration proposed the concept of validation to enhance the quality of drugs. Process validation entails verifying and documenting the process within its defined boundaries to guarantee that the generated product meets predefined standards and quality attributes with consistent and repeatable output. [2] Thorough evaluation of several factors, including the selection of premium components and materials, effective product and process design, process regulation, and both in-process and final product testing, ensures product quality assurance. Routine end product testing often proves inadequate for guaranteeing product quality owing to the intricacy of contemporary medical gadgets for several causes [3]. The sensitivity of some end-product tests is limited. The primary objective of dosage form design is to get a uniform therapeutic response to a medication in a formulation that can be produced on a large scale with consistent product quality. Process validation is a critical element in acquiring and maintaining the quality of the final product. It is crucial for guaranteeing the identity, purity, safety, and efficacy of the final product while maintaining its quality. A medication must be produced to be appropriate for its intended use, in accordance with the basic principle of quality assurance. A comprehensive understanding of the processes and their functionality is crucial for compliance with this recommendation [4]. The testing and inspection of both in-process and finished goods cannot adequately ensure quality; rather, it must be included into the manufacturing processes. Regulating these operations is essential to guarantee that the finished product meets all quality standards. The objective of process validation is to establish that the proposed production technique is suitable and reliably yields a product of the requisite quality, indicating that the approach is both appropriate and controlled. [5]
Overview of pharmaceutical systems requiring validation
The primary objective of the pharmaceutical business is to constantly provide a safe, effective, and high-quality product that adheres to established standards, while minimizing costs. The industry has devised quality and safety practices that minimize associated risks [6]. The implementation of Good Manufacturing Practices (GMP) in the pharmaceutical sector represented a little advancement in operational procedures but a significant leap in mitigating risks to patients and operators, as well as in minimizing financial losses within the business. Furthermore, the validation technique is one of the most essential methods to guarantee Good Manufacturing Practice (GMP) [7, 8].
Validation emphasizes the systematic preservation of quality throughout the production process of completed goods. A comprehensive procedure is validated, and each step is confirmed.
Validation does not contribute to process enhancement but guarantees that processes have been adequately designed and are maintained under control. It is a fundamental necessity of regulatory agencies and a potential for improvement within the pharmaceutical sector.
To execute all necessary validation actions in the industry promptly and without mistake, each business formulates a Validation Master Plan (VMP) prior to the commencement of the new financial year [9]. The plan outlines the whole of the validation activities, including its action plan, content, organizational structure, and scheduling. The primary components of VMP are the inventory of objects for validation and the planning schedule. All validation protocols pertaining to essential technical activities, applicable to product and process controls within an organization, must be included into the validation master plan.
Definitions of Validation
A) US FDA Definition “Process validation is establishing documented evidence that provides a high degree of assurance that a specified process will consistently produce a product meeting its predetermined specifications and quality characteristics.”
B) European commission “Documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its predetermined specifications and quality attributes”.
C) WHO Definition “The documented act of proving that any procedure, process, equipment, material, activity or system actually leads to the expected result.”
History of Validation
The validation concept was first introduced by two FDA officials, Ted Byers and Bud Loftus, in the 1970s to enhance the quality of the pharmaceutical industry. This idea was established due to issues related to the sterility of the big volume parenteral market. Initially, validation initiatives focused on the product manufacturing processes, but gradually extended to include other related pharmaceutical procedures as well [10]. In 1976, the FDA suggested a comprehensive set of current Good Manufacturing Practice requirements, which have been updated many times. The pharmaceutical sector adheres to them as an aspect of effective management and commercial practice. The U.S. Food and Drug Administration was the forerunner in promoting the notion of process validation, and after September 29, 1978, the definition of process validation was published in U.S. FDA literature [11, 12].
Scope of Validation
Pharmaceutical Validation is an extensive part of work that practically covers every aspect of pharmaceutical processing activities. A systematic look at the pharmaceutical operations clarifies the following areas for pharmaceutical validation
Scope of the validation
Validations conducted in Pharmaceutical Industries –
In manufacturing, methods and systems used that could affect product quality must be defined and validated.
Process validation is a quality assurance activity enabling a high degree of assurance, that a certain process will reliably produce a product that meets its specifications and quality characteristics supported by documented evidence. Process validation should assure that process performance is consistently evaluated and monitored. A validated process needs continuous monitoring to determine if there have been substantial process changes. As these changes can involve equipment, standard operating procedures, manufacturing instructions, environmental conditions or any area within the processing system. [13].
Different types of pharmaceutical process validation include:
This type of validation is usually done in the product development stage with at least three consecutive production size batches. The validation protocol is implemented before the process is commercially implemented. In the product development stage individual stages of the production process are performed. Each & every operational step is assessed on the practical or theoretical basis of a several series of experimental protocols to explore the critical parameters which may affect the quality of the final product [14].
A few series of experiments are produced to explore and measure the criticality of parameters. Each experiment is fully planned and documented in an authorized protocol. All equipment, facilities, and analytical testing methods used should always be fully validated. For the supply or selling of validation batches, the conditions under which they are made should comply fully with Good Manufacturing Practice, that is also true together with a satisfactory output from the validation activity, and a marketing authorization [15].
In this type of validation process, the company will sell the product, at its market price to the public, during the qualification runs similar to prospective & retrospective validation. This validation consists of in-process monitoring of critical processing operations and testing of the on-product. This provides the potential generation and documented evidence to show that the manufacturing process is in a control state [16]. In a non-ordinary circumstance, it is possible that a validation programme does not have to be completed in totality before commencing routine commercial batches. The rationale for performing concurrent validation must be explained briefly and documented, then approved by authorized personnel. The level of documentation required for concurrent validation is the same as has been described for prospective validation.
This validation is also helpful to a product already in distribution. Process validation is based on the previous production, testing and control data. It does also show that the process has always remained in a control state, and does what it is supposed to do. Retrospective validation can be done based on data related to a well-established process and is usually not adequate if recent changes in composition, operating procedures or equipment have been made. Validation of retrospective processes will usually be based on historical data [17].
Revalidation is typically performed in the system when there is a significant change to the process (i.e. circumstances surrounding the production process, facility, equipment, existing product, or the adding of a new product). Revalidation ensures that any changes do not detrimentally impact the process characteristics and product quality. The documentation requirements for revalidation will be the same as with the original validation of the process. Periodic evaluations should also be conducted to ensure that the process and/or products as part of the manufacturing process, including cleaning remain in an invalid state [18, 19].
Following some of the changes that require validation are as follows:
The validation of analytics is closely linked to the methods used for in-process, stability testing, and final control validation. For either pharmaceutical product or the product ingredient, the analytical monitoring is essential to make certain that the product's safety and efficacy are preserved at every stage of its shelf life, including storage, distribution, and use [20]. Monitoring should be done according to the specifications and formulated during product development. The analytical validated outcomes should be suitably consistent, reproducible and reliable outcomes for the intended purpose [21].
Verification of cleaning methods confirms that designated facilities, production sites, equipment, quality controls sites etc. receive cleaning in accordance with specifications. In this case of production equipment, the verification should establish that the contamination from the previous product; detergent or microbes has been reduced to a specified level. It must be set up a documentation system that accurately identifies the previous batch and shows the equipment was cleaned properly [22].
In this validation, the complete computerized system made up of input data, electronic processing, and output information for use in automatic control or for reporting purposes are validated [23]. Appropriate installation qualification and operational qualification has demonstrated the appropriateness of computer hardware and software to perform the intended task. Where computerized systems are used to control a GMP-related processing activity and the computerized system stores and retrieves data that has GMP implications, they are validated. Computerized systems validation ensures sufficient control is in place to prevent unauthorized access to, or amendments of, the data [24]. In the event the computerized systems are compromised leading to failure or breakdown and there may be loss of critical record, a backup and recovery process is in place. Where change control is invoked to modify computerized systems, changes should made in accordance with the “change control” process, which requires formal approval and documentation via testing, and revalidation [25].
Table 1.1: Validations Conducted in Pharmaceutical Industries
|
Type of Validation |
Definition |
Purpose |
When performed |
Documentation Required |
Examples / Remarks |
|
Process Validation |
Ensures manufacturing process consistently produces quality product |
To confirm process reliability and reproducibility |
During development, commercial production |
Protocols, batch records, equipment logs, validation summary reports |
Involves 3 batches for consistency check |
|
Prospective Validation |
Conducted before product release during development |
To ensure process parameters are effective before commercialization |
Pre-commercial production |
Protocols, results of trials, GMP compliance documentation |
Typically uses 3 full-scale batches |
|
Concurrent Validation |
Carried out during actual production when product is sold |
When pre-validation is impractical or urgent |
During initial commercial production |
Same as prospective; includes justification for concurrent approach |
May be used during product launch under monitored conditions |
|
Retrospective Validation |
Based on historical data for already marketed products |
To confirm previously unvalidated processes were in control |
For established products |
Historical batch records, trend analysis, deviation logs |
Not suitable if major changes occurred in product, process, or equipment |
|
Revalidation |
Re-assessment due to changes in process, materials, equipment, or site |
To ensure changes do not impact product quality |
Post any significant change |
Change control records, new validation reports |
Required for changes in raw materials, equipment, suppliers, or batch size |
|
Analytical Method Validation |
Ensures analytical methods produce reliable, reproducible, and specific results |
To validate test methods for quality control and stability testing |
During method development and transfer |
Method validation protocol, accuracy, precision, linearity, robustness studies |
Used for assay, impurity, dissolution, identification tests |
|
Cleaning Validation |
Demonstrates equipment and facilities are cleaned effectively to avoid cross-contamination |
Ensures cleanliness of production environment |
After cleaning procedures are finalized |
Sampling plans, acceptance criteria, swab/rinse test reports |
Must prove no residue from previous product, cleaning agents, or microbes |
|
Computer System Validation |
Validates software/hardware systems used in GMP activities |
Ensures systems perform as intended, securely and reliably |
Before implementation and after updates |
IQ/OQ/PQ documents, user requirement specs, change control records |
Includes data integrity, access control, backup/recovery mechanisms |
Need for Validation of Stability Chambers and Water Systems
Validation of stability chambers is crucial and will ensure that controlled environmental conditions (temperature, relative humidity, and light) remain constant and within the verified limits throughout the duration of the study [26]. Stability chambers play a crucial role in pharmaceutical stability studies as they provide a realistic simulation of storage conditions according to guidelines established by ICH (especially Q1A(R2)) [27]. If the chamber is not properly validated, there is a risk that the drug products could degrade undetected, leading to inaccurate prediction of shelf-life or even causing unsafe or ineffective product use. In summary, validation provides documented verification that the chamber operates reliably and uniformly, ensuring adherence to regulatory regulations and patient safety.
Similarly, validating pharmaceutical water systems—whether they generate Purified Water (PW), Water for Injection (WFI), or Highly Purified Water—is important because water is a commonly used raw material and cleaning agent in pharmaceutical processes [28]. Any potential microbial or chemical impact sources in water will directly impact product quality and safety. Furthermore, a validated water system guarantees the consistent production of water meeting pharmacopeial specifications (as required in IP, USP, EP) in relation to conductivity [29], TOC, microbial load, and endotoxins. All of this increases adherence to Good Manufacturing Practices (GMP), as well as limiting the risk of batch failures or product recalls.
Stability chambers and water systems are both key components of the quality assurance program in the pharmaceutical industry. Their validation indicates conformity to Indian Pharmacopoeia (IP) 2022 and international standards, thereby reinforcing a quality standard for all product batches [30]. Additionally, validation is not a one-time activity, it is a continuous activity, which requires regular calibration, qualification (IQ/OQ/PQ), and monitoring, and supports data & record integrity, audit readiness, and good manufacturing practices, while also supporting the backbone of a well-built pharmaceutical quality system (GxP) [31].
Overview of Stability Chambers
Stability chambers are specialized environmental devices that provide controlled temperature and humidity conditions to assess the stability of a pharmaceutical product under defined storage conditions [32]. Stability chambers create controlled environmental stresses that simulate the real world and accelerated environmental stresses from which drug substances and drug products may be subjected to throughout their lifecycle. The central thesis of Stability chambers is reproducibility and uniformity of the environmental conditions under investigation, allowing for the generation of scientifically valid stability data under ICH Q1A(R2) and/ or Indian Pharmacopoeia 2022 guidance [33]. This data is vital to determine the retest period or shelf-life of drug products, and supports regulatory submissions and market authorizations.
Typically, key factors controlled by the stability chamber include temperature (e.g. 25°C ± 2°C, 30°C ± 2°C, 40°C ± 2 °C) and relative humidity (e.g. 60% ± 5%, 65% ± 5%, 75% ± 5%) [34]. To ensure the integrity of the data throughout stability studies, controlled temperature and humidity conditions must be reliably and continuously provided with calibrated sensor and alarm systems. Deviations from specified parameters will invalidate any generated results, which can in some cases lead to the drug product batch being rejected [35]. Stability chambers must undergo a rigorous qualification process (which includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)) to show that the stability chamber can maintain specified environmental control conditions reliably over time and space [36].
Types of Stability Studies and Role in Shelf-life Determination
There are three basic categories of stability studies, namely, long-term (also called real time), accelerated species), and intermediate studies. Long-term studies are designed to mimic actual storage conditions over long periods (e.g. 12-60 months), usually at 25°C/60% RH, or 30°C/65% RH. Accelerated studies place test products under even greater stress (e.g. 40°C/75% RH) for a shorter period of time (e.g. 6 months) to obtain reasonable trends on longer-term stability as well as potential chemical degradation pathways [37]. Intermediate studies (e.g. 30°C or 65% RH) are designed when limited but significant changes are manifest under accelerated conditions or when regulatory obligated to do so. Each study is used to assess a product’s physical, chemical, microbiological, and therapeutic stability and integrity under selected conditions [38].
The data generated from these studies using validated stability chambers provides the basis for determining shelf-life and storage conditions of a product. It provides the basis for placing an expiration date on a product and assuring that the product maintains its quality, safety, and efficacy for the period in which it is intended for use. Stability study, in addition to determining expiration dates, is also useful for identifying proper packaging systems, for identifying potential degradation products, and for establishing compliance against international regulatory expectations. Stability chambers by mimicking different climate zones play a central role for determination of global pharmaceutical development and management of product lifecycles [39].
Overview of Water Systems in Pharmaceuticals
Pharmaceutical water systems are systems that are designed to produce, store and distribute water suitable for use in pharmaceutical manufacturing that meets stringent quality standards. These systems are vital to ensuring that drug products meet safety and efficacy standards. The types of water used in pharmaceutical production (i.e., Purified Water (PW) and Water for Injection (WFI)) are clearly defined in pharmacopeias such as the European Pharmacopoeia (Eur.Ph), United States Pharmacopeia (USP) and Japanese Pharmacopoeia (JP) [40].
It is crucial to manage the quality of process water in pharmaceuticals manufacturing and for the sterilization of containers or medical devices in any other healthcare assets include process water quality management, starting with the water for injection. Process waste waters are a term used to define waste waters from any industry that is related to the processed workmanship of the industry. Process waste waters cover any water which helps in the production of byproducts, waste products, raw materials, products, intermediates which are handled in different unit operations/processes [41].
Types of water
Purified Water (PW) is a water of suitable quality for pharmaceutical (USP) water use primarly to make non-parenteral formulations, such as oral liquids and topical products, and to perform cleaning processes of equipment and manufacturing environments. PW is produced by one or more types of suitable purification methods, which include deionization, reverse osmosis, ultrafiltration or distillation depending on the facility design and source water [42]. The PW should meet the chemical, microbiological and conductance limits in the relevant official pharmacopoeia's (IP, USP, EP, etc.). It should not contain any heavy metals, organics, chlorine, or microorganisms. Although PW is not considered sterile, PW must be free of pathogens, and microbial control procedures should be applied (with bioburden typically <100 CFU/mL). PW is stored most typically in 316L stainless steel tanks with continuous recirculation loops and most often does not exceed a temperature of 70-80oC to suppress microbial growth [43].
Water for Injection (WFI) is the most crucial and highest purity pharmaceutical grade water used in the manufacture of parenteral drugs (injectables), sterilized products and cleaning of aseptic/sterilized equipment. . Total organic carbon (TOC), conductivity, microbial limits (<10 CFU/100mL - typically), and acceptable endotoxins (NMT 0.25 EU/mL) [44] have extremely stringent limits for WFI. Water for Injection is usually made by either multiple-effect distillation (MED) or vapor compression distillation (VCD), but acceptable in some areas by reverse osmosis and post ultrafiltration. WFI by definition is not sterile, and must be used immediately or maintained in a controlled manner (e.g., >70?C, continuous circulation, or sterile) [44]. WFI distribution systems are required to be routinely sanitized and have to be designed with a slope to enable total drainage and reduce potential stagnation. Water for Injection is critical in sterile manufacturing processes with regard to sterility assurance levels (SAL) [45].
Sterile Water for Injection (SWFI) encompasses the same properties as Water for Injection (WFI) and is provided in single-use containers of any volume between 1 mL to 1000 mL. SWFI is free from any antimicrobial agents and all other added ingredients. It is usually used to dilute or dissolve injectable drug preparations that are parenteral routes such as intramuscular, intravenous, or subcutaneous injections [46]. Also, it will conform to sterility, particulate, pH, and endotoxin monographs from any pharmacopoeia. SWFI is not designed as bulk WFI for manufacturing; instead, it is used ready-to-administer at the point of care, however, care must be taken that this as sterile water does not have preservatives incorporated to limit microbial growth, also it should be used only under aseptic conditions, and after opening that day. There are labeled conditions to store it in and it must be stored in pyrogen-free, sterile, sealed containers to ensure integrity of the product [47].
Water for Hemodialysis is a distinct form of water used in dialysis centers to prepare dialysate solutions; dialysate solutions are substances consumed by the patient indirectly since the dialysate passes with the bloodstream through a semi-permeable membrane in the dialysis machine. Water used in hemodialysis must be treated to remove chemical contaminants (e.g., aluminum, chloramines, nitrates, fluoride) and microbial contaminants to protect patients [48] . Typically this treatment involves pre-filtration, carbon activated filtration, water softening, reverse osmosis, ultrafiltration, if necessary an online disinfection system. Due to the volume of water a patient receives weekly, between hundreds of liters of water; it is important to follow standards set forth by organizations such as the AAMI (Association for the Advancement of Medical Instrumentation) or a particular pharmacopoeia with some modifications. Limits on microorganisms are usually <100 CFU/mL, and limits on endotoxins <0.25 EU/mL. Monitoring as well as routine validation is vital since contamination could cause serious life-threatening complications in patients [49].
Sterile Water for Inhalation is sterile, non-pyrogenic water used to humidify respiratory gases, prepare solutions for nebulizers, and dilute inhalation medications. It is produced according to good manufacturing practices (GMP) and is sterile, pure, and meets pharmacopoeial requirements, with limits for endotoxins which may be slightly higher than those established for SWFI, due to the route of administration, being pulmonary rather than parenteral [50]. Sterile Water for Inhalation does not contain antimicrobial preservatives, should be used immediately after opening, is not to be used intravenously or intramuscularly, is supplied in containers suited for inhalation delivery systems, has traditional use in hospitals and intensive care units, and as a component of home oxygen therapy systems to facilitate patient hydration and comfort [51].
Bacteriostatic Water for Injection (BWFI) contains a bacteriostatic substance, typically benzyl alcohol (0.9 percent), that stops or slows down the growth of most organisms. BWFI is supplied in multi-dose vials and may be used to dilute, or dissolve medications for parenteral administration when multiple withdrawals will occur. BWFI meets the same chemical purity and sterility standards as sterile water for injection (SWFI) with an additional preservative that allows short-term multiple use. BWFI should not be used in neonates or infants because of benzyl alcohol's potential toxicity which can result in "gasping syndrome". BWFI has limited maximum administration volume due to it preserves content. BWFI is a practical and economical option in clinical environments for reconstitution of multiple dose drugs, but it must be used prudently with regard to patient safety and compatibility [52].
Regulatory Guidelines and Indian Pharmacopoeia (I.P.) 2022 Standards
Overview of Validation Requirements in I.P. 2022
According to the Indian Pharmacopoeia (I.P.) 2022 all critical systems and equipment that have an effect on product quality, safety and efficacy, such as stability chambers and pharmaceutical water systems, must be validated to Good Manufacturing Practices (GMP) [53]. Validation is considered necessary to demonstrate documented evidence that equipment operates consistently within stated specifications until it operates as designed each time within the conditions of actual use. Stability chambers for ICH compliant storage conditions and pharmaceutical water systems for production, cleaning and analytical purposes are categorized as critical utilities, and must be validated before they are utilized. Validation requirements are consistent with regulatory expectations in Schedule M of the Drugs and Cosmetics Rules, and supplemented by relevant general chapters and appendices of I.P. 2022 [54].
Reference to Annexures and Relevant General Chapters
I.P. 2022 provides multiple appendices, as well as general monographs, on important aspects of validation. Appendix 5.1, Validation of Analytical Procedures; Appendix 6.1, Environmental monitoring; and Appendix 3.1, Microbiological Quality of Water, provide guidance on analytical systems, cleanroom environments, and water systems validation respectively [55]. Although the pharmacopoeia does not includes a separate annex solely on the validation of equipment or utilities, it does recognize the need for environmental chambers and water systems to be qualified using validated protocols. In addition, the general chapter titled “storage conditions” provides temperature and relative humidity ranges that must be maintained and controlled using validated stability chambers for accelerated (40?±?2°C/75?±?5% RH), long-term (25?±?2°C/60?±?5% RH), and intermediate (30?±?2°C/65?±?5% RH) studies. The Microbiological Specifications chapter also describes acceptable limits for microbial loads for types of water (e.g., Purified Water, WFI) [56].
Cross-reference with ICH Q1A (R2) and WHO TRS 1010 (Annex 2)
Validation methods detailed in I.P. 2022 are aligned with international guidance such as ICH Q1A (R2) and the World Health Organization Technical Report Series (WHO TRS) No. 1010, Annex 2. ICH Q1A (R2) notes that stability studies must be performed in validated chambers qualified for the proposed environmental conditions, using continuous environmental monitoring systems and alarms. Likewise, WHO TRS Annex 2 describes the validation lifecycle of HVAC systems, clean utilities (pharmaceutical water systems), and chambers. These guidance documents indicate utilities must be validated by robust sampling programs, mapping studies, and routine performance checks to mitigate all-risk factors and provide reproducibility. Further, there is guidance from the WHO and ICH with reference to the necessity for periodic requalification of systems and utility lifecycle management [57].
Specific Validation Parameters (DQ, IQ, OQ, PQ)
Validation of stability chambers and water systems must be executed through a structured qualification lifecycle comprising four key stages:
All validation activities must be documented comprehensively, including protocols, raw data, deviations, summary reports, and certificates of calibration and traceability. Validation Master Plans (VMP), SOPs, and requalification schedules must be in place to ensure continued compliance throughout the system lifecycle.
CONCLUSION
Future developments in validation of pharma water systems, and stability chambers should increasingly leverage the power of digital technologies and data-based approaches. The enhanced use of IoT (sensor) technology, cloud data logging solutions, and real-time analytic techniques will enable continuous monitoring and ultimately decrease manual errors, and facilitate predictive maintenance - including automated alarm systems, and centralised dashboards for supporting document deviations and regulatory audit readiness. Even moving to an increasing use of risk-based validation approaches under the Quality Risk Management (QRM) concept will bring a more efficient use of resources, including direct qualification of re-qualification.
REFERENCES
Vinay Kumar, Amit Kumar, A Review on the Preparation and Validation of Stability Chambers and Water Systems in Accordance with Indian Pharmacopoeia (I.P.) 2022, Int. J. of Pharm. Sci., 2025, Vol 3, Issue 7, 2598-2612. https://doi.org/10.5281/zenodo.16094773
10.5281/zenodo.16094773
