WebOfPharma · PIC/S GMP
PIC/S Cleaning Validation Requirements Explained
A practical, inspection-ready guide to PIC/S cleaning validation: risk assessment, HBEL and MACO limits, sampling, recovery, documentation, verification, and lifecycle control.
PIC/S cleaning validation requirements are practical expectations for demonstrating that equipment is fit for the next product. They are not satisfied by a generic protocol, a visual check alone, or a fixed number of successful swabs. A defensible program connects product toxicology, equipment design, cleaning development, analytical science, operator performance, and the pharmaceutical quality system.
This article explains the current PIC/S framework for pharmaceutical manufacturers, contract manufacturers, Quality Assurance, Quality Control, Production, Engineering, Validation, toxicology, and Qualified Person review. It also shows how PIC/S requirements connect with cGMP, equipment qualification, data governance, and the wider Cleaning Validation in Pharmaceuticals lifecycle.
What Are PIC/S Cleaning Validation Requirements?
PIC/S cleaning validation is documented evidence that an approved cleaning procedure will reproducibly remove the previous product, relevant by-products or degradation products, and cleaning agents from equipment below a scientifically established maximum allowable carryover level, while maintaining microbial control. The purpose is to prevent chemical and microbiological cross-contamination and to protect the identity, strength, quality, purity, safety, and efficacy of the next medicinal product.
PIC/S treats cleaning validation as a lifecycle activity. Cleaning development identifies critical parameters and creates a reproducible process; the validation study challenges that process under justified conditions; and ongoing evaluation confirms that the process remains in control during routine manufacture.
PIC/S Regulatory Framework for Cleaning Validation
The PIC/S GMP Guide and its supporting recommendations should be read together. The exact legal status of a document depends on how the relevant participating authority has adopted it, so a site must always check applicable national requirements and current authority communications.
| PIC/S reference | What it contributes | How to use it in a cleaning program |
|---|---|---|
| PE 009 GMP Guide | Core GMP principles for premises, equipment, production, documentation, quality systems, and contamination control. | Use it as the governing GMP baseline and map local requirements to the site quality system. |
| Annex 15 | Harmonised qualification and validation principles, including the core EU/PIC/S cleaning-validation expectations. | Use it to structure lifecycle planning, protocols, acceptance criteria, deviations, and validation reports. |
| PI 006-4 | Detailed PIC/S Recommendations on Qualification and Validation, including a dedicated cleaning-validation section. | Use the cleaning-specific recommendations for scope, equipment, personnel, sampling, methods, limits, and maintaining control. |
| PI 046 | Guideline for setting health-based exposure limits in shared facilities. | Use the toxicological assessment as an input to cross-contamination risk management and cleaning-limit decisions. |
| PI 052-1 and PI 053 | Inspector-focused HBEL assessment and Q&A material for risk-based cross-contamination controls. | Use them to test whether the HBEL report and the site’s practical controls are complete and credible. |
| PI 041 | Good practices for data management and integrity in regulated GMP/GDP environments. | Apply data-integrity controls to sampling, laboratory files, electronic recipes, audit trails, calculations, and approvals. |
PI 006-4 Cleaning Validation: The Three-Part Program
PI 006-4 describes a cleaning-validation program as three connected activities. Treating only the middle activity as “validation” creates gaps in process understanding and routine control.
Cleaning development
Identify critical cleaning parameters and design a procedure that is controlled, reproducible, and suitable for the equipment and residue challenge.
Validation study
Perform a predetermined number of cleaning verification assessments to confirm consistent and effective cleaning under justified conditions.
Ongoing evaluation
Trend manual and automated cleaning after validation and confirm that the equipment remains in a state of control.
Risk-based scope
Use documented Quality Risk Management to decide the depth, breadth, frequency, and analytical intensity of the program.
Scope: Products, Equipment, and Contamination Risks
PIC/S recommendations apply directly to finished-product manufacture and provide supplementary guidance for APIs. The scope should include product-contact surfaces and non-contact parts from which residue could migrate into a future product. Examples include seals, flanges, mixing shafts, oven fans, heating elements, filters, screens, transfer lines, and difficult-to-drain points.
Manufacturers should normally validate each item of equipment. A grouping or “like-for-like” approach is acceptable only when the equipment is genuinely equivalent or differences are justified and practically confirmed not to affect cleaning consistency. Drawings, surface finishes, geometry, access, drainage, cleaning coverage, and residue behaviour should support the rationale.
Product changeover and development batches
Cleaning procedures for product changeover should be fully validated following suitable coupon testing and recovery studies. Cleaning validation should normally begin when commercial production starts, but it may begin earlier during development when the cleaning process is fully defined and the formulation and manufacturing process represent intended commercial production.
When full validation is not yet complete, release of equipment based on cleaning verification data requires a documented risk assessment. The assessment should consider the risk of later verification failures and the potential impact on commercial or clinical product.
Quality Risk Management and HBEL-Based Limits
The starting point for a PIC/S cleaning-validation program is a documented risk assessment. The assessment determines the scope, effort, sampling design, controls, verification frequency, and need for dedicated equipment. For shared facilities, the product’s health-based exposure limit (HBEL), commonly expressed as a permitted daily exposure (PDE), is a key input to the cross-contamination assessment.
An HBEL is a toxicological hazard indicator, not automatically the final surface acceptance limit. The site must translate the toxicological information into practical, achievable, and verifiable controls. The final decision should account for product dose, potency, solubility, cleaning difficulty, equipment surface area, batch size, process-train carryover, unit-dose contamination, analytical capability, and safety margin.
What PIC/S expects in a limit rationale
Document the source and approval of the toxicological assessment, the critical effect or point of departure, adjustment factors, route-of-administration considerations, assumptions, calculations, safety margins, cleaning-agent limits, microbial limits, and the reason the chosen limit is practical and verifiable. Link the limit to the actual equipment train rather than treating it as an isolated number.
MACO and process-train effects
Calculate acceptance criteria for individual equipment and for the cumulative carryover across multiple shared equipment items. Do not assume that residue is uniformly distributed through a batch or over a surface. A local deposit may contaminate the beginning of a batch, a unit dose, a compression feed, an encapsulation stream, or primary packaging disproportionately.
Products with very low HBEL values may need additional controls, such as dedicated parts, automation, containment, analytical monitoring at every product changeover, or a dedicated facility. The choice should be based on the complete QRM assessment, not on the HBEL number alone.
Worst-Case Products, Bracketing, and Grouping
A worst-case approach can reduce the number of studies when product and equipment risks are understood. The justification should consider HBEL, cleaning difficulty, solubility in water and cleaning agents, residue characteristics, equipment geometry, surface materials, batch size, and prior experience.
One product may be the hardest to clean while another is the more hazardous carryover risk. For example, an insoluble product with a high HBEL may require more mechanical cleaning, whereas a partially soluble product with a very low HBEL may require tighter analytical and organisational controls. Multiple worst-case products may therefore be needed.
Bracketing or matrixing should identify the tested extremes and explain why intermediate products, strengths, batch sizes, or equipment configurations are represented. The rationale should be scientific, risk-based, and confirmed in practice where equipment differences could influence cleaning.
Cleaning Process Controls Under PIC/S
Manual cleaning
Manual cleaning is inherently variable and requires detailed instructions, trained or qualified operators, appropriate oversight, and complete records. The procedure should define equipment preparation and disassembly, cleaning-agent identity and concentration, soaking or scrubbing technique, tools, contact time, temperature, rinsing, drying, and inspection.
Measuring devices used during manual cleaning should be calibrated. Operators executing validation swabs should be trained to follow the same technique used during recovery studies. Visual failures, including failures found during a second-person check after manual cleaning, must enter the Quality System and be investigated.
Automated and CIP cleaning
Automated procedures should define the cleaning sequence, temperatures, concentrations, number of applications, valve openings, spray rates, pressures, volumes, and any required disassembly. Sensors, alarms, calibration, qualification, maintenance, and alarm-response instructions should support consistent performance.
Cleaning recipes and data must be controlled, reviewed, and protected from accidental or intentional modification or deletion. Data integrity should be designed into automated equipment and assessed before installation. Link the system requirements to the site’s URS, DQ, IQ, OQ, and PQ process.
Dirty hold time, clean hold time, and campaign length
PIC/S expects evidence for the allowable time that equipment may remain dirty before cleaning and the allowable time cleaned equipment may be held before use. Assess drying, residue hardening, degradation, microbial growth, environmental exposure, storage configuration, and protection from recontamination.
Define the maximum campaign length by both time and number of batches unless a documented rationale supports another approach. Consider residue build-up, processing impact, microbiological controls, and whether a long campaign changes cleaning effectiveness.
Visual Inspection and Microbiological Control
Visual inspection should be performed and documented after every cleaning activity, once the equipment has dried. “Visually clean” is the minimum standard, but visual inspection should normally be combined with surface or rinse sampling using a validated method sensitive below the residue limit.
Where visual inspection is proposed as a decision criterion, establish the visibility threshold under the lighting, background, viewing distance, access, mirror, and borescope conditions used in production. Low-HBEL residues may be below the visual-detection threshold; in those situations, cleaning verification at every product changeover may be necessary.
Microbiological risk assessment should address moisture, temperature, crevices, rough surfaces, long storage, and the time between cleaning and reuse. Equipment should generally be stored dry, and stagnant water should not remain in the equipment. Biological products and long process times may require particular attention to bioburden control.
Sampling and Recovery Requirements
Sampling must follow the approved protocol and use locations selected from a documented equipment assessment. Direct surface sampling, such as swabbing or wiping, is generally preferred when feasible because it can target difficult-to-clean areas. Rinse sampling is useful for large or inaccessible surfaces, but it can average results and dilute a localised deposit. A combination may be needed.
| Sampling approach | PIC/S expectation | Key control |
|---|---|---|
| Swab or wipe | Define solvent, swab material, area, location, technique, extraction, and recovery correction. | Demonstrate recovery from each relevant material, such as stainless steel, plastic, silicone, or coated surfaces. |
| Rinse sample | Use for large or inaccessible areas when the contaminant is soluble and the method represents production rinsing. | Address averaging, dilution, solubility, rinse volume, flow path, and recovery from all construction materials. |
| Microbial surface sample | Apply comparable site-selection principles using sterile components and suitable recovery controls. | Validate or qualify the method for relevant pharmacopoeial and local isolates. |
| Visual examination | Inspect dried equipment under suitable lighting and document the result after every cleaning. | Train and qualify inspectors; investigate every failure. |
Recovery studies should reflect actual materials of construction, surface finish, solvent, swab, extraction, and technique. A correction factor may be needed for incomplete recovery, but it must be scientifically justified and consistently applied. Sample collection and analysis should preserve sample integrity by defining the time from sampling to analysis and storage conditions.
Analytical Methods, Detergents, and Acceptance Criteria
Analytical methods used for product residues, degradants, microbial contamination, and detergent residues should be validated or otherwise shown suitable for their intended purpose. Determine specificity or selectivity, detection and quantification limits, accuracy, precision, recovery, sample stability, and possible interference from cleaning chemistry or surface materials.
Specific methods are generally preferred. TOC or conductivity may be used when justified, especially when specific residue analysis is not feasible or interference prevents a specific method. In that case, the site must demonstrate reproducible sampling recovery and use a conservative interpretation of the result.
The detergent composition should be known. Define an acceptable detergent-residue limit and ideally demonstrate that no meaningful residue remains. Supplier change notifications should be controlled because a detergent-formulation change can affect cleaning performance, residue risk, method suitability, and validation status.
PIC/S Cleaning Validation Protocol Requirements
The protocol is the controlled plan for the validation exercise. It should be more specific than the routine SOP and approved by Production, the Quality Unit, and other appropriate departments before execution.
- Objective and scope: products, equipment, cleaning systems, changeover, campaign, and validation boundaries.
- Responsibilities: Production, Quality Control, Quality Assurance, Engineering, Validation, toxicology, contractors, and approvers.
- Prerequisites: qualified equipment, approved cleaning procedure, trained personnel, calibrated instruments, approved methods, and defined safety controls.
- Risk assessment: HBEL, worst-case products, non-contact migration, equipment grouping, hold times, campaign length, and manual or automated variability.
- Cleaning procedure: detergent, concentration, temperature, contact time, mechanical action, flow, pressure, rinse, drying, disassembly, and alarms.
- Number of consecutive cycles: a predetermined, risk-justified number sufficient to demonstrate consistency.
- Sampling plan: method, solvent, locations, area, tools, containers, labels, sample custody, and recovery correction.
- Analytical plan: method, specificity, LOQ, LOD, system suitability, sample stability, calculations, and reporting rules.
- Acceptance criteria: visual, chemical, cleaning-agent, microbial, endotoxin, toxicological, and cumulative equipment-train criteria as applicable.
- Bracketing or matrixing: products, processes, strengths, batch sizes, or equipment configurations represented by the study and the supporting rationale.
- Deviation handling: rules for unexpected events, invalid samples, excursions, retesting, investigation, and impact assessment.
- Report and ongoing control: conclusions, limitations, equipment-release decision, verification frequency, revalidation triggers, and follow-up actions.
PIC/S Cleaning Validation Records and Data Integrity
Cleaning records should make the activity reconstructable. At minimum, retain the area or equipment cleaned, the person who performed the cleaning, the date and time, the cleaning SOP, the previous product, visual-inspection result, and data or printouts obtained during cleaning. The operator, supervisor where applicable, and visual inspector should sign or electronically approve the record.
Apply ALCOA+ principles to swab maps, sample labels, laboratory worksheets, chromatograms, audit trails, electronic cleaning recipes, calculations, and approvals. Preserve original results, invalid runs, reinjections, failed visual inspections, deviations, and retests. Electronic controls may also need to align with applicable 21 CFR expectations when electronic records support a US-regulated product.
Cleaning Validation Report and Quality Oversight
The final report should state whether the cleaning process met every approved acceptance criterion. It should include the executed protocol, raw-data references, results, deviations, investigations, recovery information, calculations, limitations, learning points, equipment-release decision, and requirements for ongoing verification or revalidation.
External consultants, laboratories, and equipment suppliers may support the work, but the manufacturer remains responsible for regulatory compliance and quality oversight. Management should provide enough personnel, time, laboratory capacity, engineering support, and training to complete the study without shortcuts.
Cleaning Validation Versus Cleaning Verification
Cleaning validation demonstrates that the approved process can reproducibly clean equipment. Cleaning verification is the analytical or other evidence gathered after a batch or campaign to confirm that a particular equipment item has been cleaned. Verification may be used during development, while validation is ongoing, for manual cleaning that cannot be fully validated, or as routine monitoring for high-risk products.
PI 006-4 highlights continued verification for low-HBEL products, manual cleaning, residues below visual detection, limited validation data, and equipment or products with a history of failures or highly variable results. Products with carryover limits below visual detection, after an appropriate safety margin, should generally be considered for verification after every product changeover.
Handling Cleaning Failures and Deviations
Every cleaning failure—including a visual failure—should be recorded, investigated, and assessed for its impact on validation and verification. Continually cleaning and testing until acceptable results are achieved is not acceptable because it hides the first result and can mask an ineffective process.
Remediation may include improving the cleaning procedure, changing the detergent or mechanical action, correcting equipment design, retraining personnel, reducing campaign length, increasing verification, reassessing the HBEL or QRM, adding dedicated parts, or dedicating equipment or facilities. If systemic, use CAPA in pharmaceuticals and the site’s CAPA process with measurable effectiveness checks.
Maintaining the Validated Cleaning Process
Ongoing monitoring should be risk-based and should confirm that cleaning remains within a state of control. Trend analytical and visual results, operator observations, detergent concentration, water pressure, temperature, cycle time, alarms, failed samples, deviations, and repeat-cleaning events.
Use change control when equipment, product, process, detergent, supplier, water system, campaign length, sampling method, analytical method, or cleaning parameters change. Revalidation or personnel observation may also be appropriate at routine intervals based on risk. A new product should trigger an assessment of whether the existing worst-case rationale and cleaning matrix remain valid.
Step-by-Step PIC/S Cleaning Validation Workflow
- Confirm the applicable PIC/S version. Check PE 009, Annex 15, PI 006-4 transition timing, national implementation, and quality agreements.
- Build the equipment and product map. Identify product-contact and migration-prone non-contact parts, equipment trains, surfaces, drains, seals, and hard-to-clean locations.
- Perform the QRM and toxicological review. Link HBEL/PDE, dose, potency, solubility, cleanability, microbiological risk, and unit-dose consequences.
- Develop the cleaning process. Define critical parameters, manual steps, automated recipes, alarms, disassembly, drying, and storage conditions.
- Qualify methods and recovery. Challenge swab or rinse sampling on every relevant material; establish specificity, LOQ, LOD, stability, and microbial recovery.
- Approve the protocol. Define the consecutive cycles, worst-case conditions, hold times, campaign length, acceptance criteria, deviations, and bracketing rationale.
- Execute without selective retesting. Preserve the first result, document observations, and record all deviations and invalid samples.
- Approve the report. State the result, limitations, equipment status, verification frequency, revalidation triggers, and any restrictions.
- Trend and improve. Use routine verification, change control, periodic review, and CAPA to maintain the validated state.
Worked Example: Shared Granulation and Compression Equipment
A facility manufactures several oral-solid-dose products using a high-shear granulator, fluid-bed dryer, mill, blender, tablet press, and shared transfer bins. Product A has a low HBEL and sticky granulation residue; Product B is difficult to dissolve in the approved rinse solvent; Product C has a high daily dose but a much higher HBEL.
The risk assessment selects Product A for toxicological carryover and Product B for cleanability. It identifies the granulator impeller, dryer filter bags, mill screen, blender discharge valve, tablet-press feed frame, seals, and transfer-bin corners as high-risk locations. Swabs are used where parts can be safely dismantled; representative rinse samples are added for enclosed transfer paths. Recovery is demonstrated on stainless steel, polymer, elastomer, and filter materials.
The protocol challenges maximum dirty hold time, maximum clean hold time, maximum campaign length, approved detergent concentration, water temperature, cycle time, manual disassembly, and automated recipe alarms. Specific HPLC testing is used for Product A, a justified method is used for Product B, and detergent and microbial controls are included. The report preserves all raw data and sets a higher verification frequency for Product A until sufficient trend data support a change.
PIC/S Cleaning Validation Inspection Checklist
- Applicable PE 009, Annex 15, and PI 006 version confirmed
- Risk assessment defines program scope and effort
- All product-contact and migration-prone surfaces mapped
- Equipment grouping or like-for-like rationale practically confirmed
- HBEL/PDE and toxicological assessment approved
- MACO and process-train carryover calculations documented
- Unit-dose and non-uniform contamination risks considered
- Worst-case products and bracketing rationale identified
- Cleaning parameters and normal operating ranges defined
- Manual-cleaning training, qualification, and oversight established
- Automated recipes, alarms, sensors, calibration, and maintenance controlled
- Dirty hold time, clean hold time, and campaign length justified
- Visual inspection performed after equipment has dried
- Swab and rinse locations justified in the protocol
- Recovery demonstrated for all relevant surface materials
- Analytical specificity, LOQ, LOD, stability, and microbial recovery suitable
- Detergent composition and residue limits controlled
- Protocol includes cycle number, acceptance criteria, deviations, and approvals
- Failed results and visual failures investigated without test-until-clean practices
- Ongoing verification, change control, and revalidation triggers defined
- Cleaning records identify equipment, operator, time, SOP, previous product, and data
- Raw data, audit trails, calculations, and approvals retained under ALCOA+ controls
Common PIC/S Cleaning Validation Deficiencies
| Common gap | Why it is weak | Better practice |
|---|---|---|
| Copying Annex 15 text without a site risk assessment | The scope and controls are not connected to actual products or equipment. | Use a documented QRM assessment to define the validation matrix and verification frequency. |
| Using only a low-HBEL product as “worst case” | Low HBEL does not automatically mean the product is hardest to clean. | Assess toxicology and cleanability separately; select multiple worst cases if needed. |
| Visual inspection used as the only test | Residues below visual detection can still exceed safety limits. | Combine dried visual inspection with sensitive surface or rinse testing. |
| Rinse recovery not demonstrated | Rinse dilution or poor solubility may produce a false low result. | Demonstrate representative recovery and assess localised contamination. |
| Protocol omits process-train carryover | Individual equipment results may pass while cumulative carryover is unacceptable. | Calculate individual and cumulative equipment-train criteria. |
| Repeated cleaning and testing until pass | The original failure is hidden and process capability is overstated. | Preserve the original result, investigate, remediate, and assess impact. |
| Manual cleaning records lack operator and time detail | The activity cannot be reconstructed or linked to training. | Record equipment, person, time, SOP, previous product, inspection, and data. |
| Automated recipe changes are not controlled | Cleaning performance can change without validation review. | Protect recipes, audit trails, alarms, access, backup, and change control. |
| No ongoing verification for low-HBEL manual cleaning | Operator variability and failure history may remain undetected. | Use risk-based changeover monitoring and trend results. |
Key Takeaways
- PIC/S cleaning validation is a lifecycle program: development, validation study, and ongoing evaluation.
- PI 006-4 provides detailed cleaning recommendations and enters into force on 1 October 2026; confirm applicable transition requirements.
- HBEL/PDE informs risk management but is not automatically the final cleaning acceptance limit.
- Assess product-contact surfaces and non-contact parts from which residue can migrate.
- Use scientific worst-case, bracketing, or equipment-grouping rationales; one factor may not represent every risk.
- Swab sampling is generally preferred when feasible, while rinse sampling helps access large or enclosed surfaces.
- Demonstrate recovery, method sensitivity, sample integrity, detergent control, and microbiological recovery.
- Define dirty hold, clean hold, campaign length, manual variability, automated recipes, and alarm responses.
- Investigate all failures and never use repeated cleaning and testing until a pass result as the validation strategy.
- Maintain the validated state with verification, trend review, change control, revalidation, data integrity, and CAPA.
Frequently Asked Questions
What is PIC/S cleaning validation?
It is documented evidence that an approved cleaning process reproducibly removes previous-product residues, relevant degradation products, and cleaning agents below scientifically justified limits while maintaining microbial control.
What is PI 006-4?
PI 006-4 is the revised PIC/S Recommendations on Qualification and Validation. PIC/S published it on 30 July 2026, and its stated entry-into-force date is 1 October 2026. It supersedes PI 006-3.
Does PIC/S require a fixed number of cleaning validation runs?
PIC/S expects a predetermined number of consecutive cleaning verification assessments justified by risk and sufficient to demonstrate consistency. The number should be defined before execution, not selected after results are seen.
Is visual inspection enough under PIC/S?
No. Visual inspection after drying is an important minimum check, but it should normally be paired with surface or rinse sampling using a method sensitive below the approved residue limit. Low-HBEL products may require changeover verification.
Does PIC/S prefer swab or rinse sampling?
Direct surface sampling is generally preferred when feasible because it can target difficult-to-clean areas. Rinse sampling is useful for large or inaccessible areas. A combination may be necessary.
How does HBEL affect cleaning validation?
HBEL or PDE provides a toxicological input to cross-contamination risk assessment. The site must translate it into practical, achievable, verifiable limits and controls that also consider dose, equipment, batch, process-train, and analytical factors.
What does PIC/S expect for cleaning-agent residues?
The detergent composition should be known, cleaning effectiveness should be evaluated, and an acceptable detergent-residue limit should be defined. Ideally, no meaningful residue should remain.
Are TOC and conductivity acceptable?
They may be used when scientifically justified, especially when specific product-residue methods are not feasible. The site must demonstrate suitable and reproducible sampling recovery and interpret the result conservatively.
When should cleaning validation be repeated?
Use change control and risk assessment after equipment, product, process, detergent, water, campaign, method, or parameter changes, and after repeat failures or adverse trends. Routine revalidation or personnel observation may also be appropriate.
What is the biggest PIC/S inspection risk?
A common risk is a gap between the written protocol and actual contamination controls—for example, unsupported worst-case selection, unproven recovery, missing process-train carryover, weak manual-cleaning records, or retesting until a pass result.
Conclusion
PIC/S cleaning validation requirements are built around science, risk management, and evidence that the routine cleaning process works consistently. A strong program begins with product and equipment understanding, sets protective and verifiable limits, challenges the real worst-case conditions, proves sampling recovery, and documents every result—including failures.
As PI 006-4 approaches its 1 October 2026 entry into force, manufacturers should compare their validation master plan, cleaning matrices, protocols, data-integrity controls, verification frequencies, and revalidation triggers with the revised PIC/S recommendations. When cleaning validation is integrated with Process Validation in Pharmaceuticals, equipment qualification, CAPA new, and ongoing Quality Risk Management, the site can demonstrate sustained control across the product lifecycle.
Official PIC/S references
Regulatory note: This article is an educational summary. It does not replace the current PIC/S GMP Guide, PI 006-4, national implementation, marketing-authorisation commitments, toxicological assessment, competent-authority expectations, or approved site procedures. Confirm the applicable version and obtain Quality Unit approval before implementing or changing a cleaning-validation strategy.
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