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cGMP Batch Record Review Checklist (21 CFR 211)
Verifies that executed master and batch production records are complete, accurate, and reviewed by the quality unit before batch disposition. Use during QA batch review prior to release.
Data Integrity (ALCOA+) Assessment Checklist
Evaluates GxP data against the ALCOA+ principles to confirm records are attributable, legible, contemporaneous, original, and accurate. Use for self-inspection, supplier audits, and data governance review.
Cleaning Validation HBEL and PDE Limits Checklist
Verifies that cleaning validation carryover limits are derived from health-based exposure limits (HBEL/PDE) rather than legacy default criteria, and that a qualified toxicologist supports the assessment. Use to establish or audit HBEL-based cleaning limits.
Laboratory Information Management System (LIMS) Validation Checklist
Confirms that a Laboratory Information Management System is validated for its intended use with controls over configuration, interfaces, security, and data integrity. Use to plan or audit a LIMS validation.
EU Annex 11 Computerized Systems Compliance Checklist
Verifies that computerized systems used in GMP operations meet EU Annex 11 expectations for risk management, validation, data, security, and operational controls. Use to assess a system or prepare for an EU GMP inspection.
Electronic Batch Record Review-by-Exception Checklist
Confirms that electronic batch records and a review-by-exception model are configured, validated, and governed so that batch release remains compliant and data-integrity sound. Use to establish or audit an EBR/MES review process.
GMP Self-Inspection and Internal Audit Checklist
Verifies that a GMP self-inspection (internal audit) program is planned, independent, risk-based, and effective at driving corrective action. Use to establish or evaluate a self-inspection program.
Chromatography System Suitability Checklist (USP <621>)
Confirms that HPLC and GC system suitability testing is defined and met before and during sample analysis to ensure the analytical system performs adequately. Use to establish or audit chromatographic system suitability practices.
Microbial Identification and Characterization Program Checklist
Confirms that a microbial identification program characterizes recovered isolates to an appropriate level to support contamination control, trending, and investigations. Use to establish or audit an ID program.
Dissolution Testing Program Checklist (USP <711>)
Verifies that dissolution testing for oral and other dosage forms is properly developed, validated, qualified, and executed to assess drug release performance. Use to establish or audit a dissolution testing program.
Process Analytical Technology (PAT) Implementation Checklist
Confirms that a Process Analytical Technology system for real-time process understanding and control is designed, validated, and integrated with the quality system. Use to plan or audit a PAT deployment.
Sterilizing Filter Integrity Testing Checklist
Confirms that sterilizing-grade filters are validated and integrity-tested before and after use to ensure sterility assurance in aseptic processing. Use to establish or audit a filter integrity testing program.
Depyrogenation and Autoclave Sterilization Validation Checklist
Verifies that moist-heat (autoclave) sterilization and dry-heat depyrogenation processes are validated for lethality, endotoxin reduction, and load reproducibility. Use to plan or audit thermal sterilization validation.
Nitrosamine Impurity Risk Assessment Checklist
Guides a structured three-step nitrosamine risk assessment (evaluation, confirmatory testing, and control) for drug substances and drug products. Use to establish or audit a nitrosamine program under the current regulatory expectations.
Elemental Impurities Risk Assessment Checklist (ICH Q3D)
Confirms that elemental impurities in drug products are evaluated against permitted daily exposure (PDE) limits using a documented risk-based approach and validated analytical methods. Use to build or audit an ICH Q3D control strategy.
Residual Solvents Control Checklist (ICH Q3C)
Verifies that residual solvents in drug substances and products are classified, limited, and tested according to their toxicity class and permitted daily exposure. Use to establish or audit residual solvent controls.
Extractables and Leachables Study Checklist
Confirms that extractables and leachables studies for container closure systems, manufacturing components, and single-use assemblies are scientifically designed, toxicologically assessed, and controlled. Use to plan or audit an E&L program.
Single-Use Systems Qualification Checklist
Verifies that single-use systems and components used in biopharmaceutical manufacturing are qualified for chemical compatibility, integrity, particulates, and supplier control. Use to establish or audit a single-use qualification program.
HVAC and Cleanroom Qualification Checklist
Verifies that HVAC systems and classified cleanrooms are qualified for air classification, pressure cascade, recovery, and environmental control in sterile and non-sterile manufacturing. Use to plan or audit cleanroom qualification.
Bacterial Endotoxin (LAL) Testing Checklist (USP <85>)
Confirms that bacterial endotoxin testing by the Limulus Amebocyte Lysate (LAL) method is properly validated, controlled, and interpreted for injectable products and medical devices. Use to establish or audit an endotoxin testing program.
Sterility and Bioburden Testing Checklist (USP <71> / <61>)
Ensures sterility testing and microbial enumeration (bioburden) are validated and performed under conditions that prevent false results and support release of sterile and non-sterile products. Use to audit the QC microbiology program.
Visual Inspection of Parenterals Checklist (USP <790>)
Confirms that injectable products are 100% inspected for visible particulates and defects and that the inspection program is validated with qualified inspectors and defect libraries. Use to establish or audit visual inspection.
Lyophilization (Freeze-Drying) Process Control Checklist
Verifies that a lyophilization cycle is designed, controlled, and monitored to produce a robust, sterile freeze-dried product with consistent critical quality attributes. Use during cycle development, validation, and routine control review.
Cell and Gene Therapy cGTP Checklist (21 CFR 1271)
Confirms that human cell, tissue, and cellular/tissue-based product (HCT/P) manufacturing meets Current Good Tissue Practice requirements for donor eligibility, chain of identity, and contamination prevention. Use to audit a CGT manufacturing operation.
Contamination Control Strategy (CCS) Checklist (EU GMP Annex 1)
Confirms that a holistic, documented Contamination Control Strategy links facility design, process, and controls to a defined understanding of microbial, particulate, and pyrogen risks. Use to build or assess an Annex 1 CCS.
Quality Risk Management Checklist (ICH Q9)
Confirms that quality risk management activities follow a structured, science-based process for risk assessment, control, communication, and review with appropriate rigor and subjectivity control. Use to establish or audit the QRM program.
Continued Process Verification (Stage 3) Checklist
Confirms that an ongoing Stage 3 program monitors commercial process performance to ensure the process remains in a state of control after validation. Use to establish or audit continued process verification.
Retain and Reserve Samples Checklist (21 CFR 211.170)
Confirms that reserve (reference) samples of active ingredients and finished products are collected, stored, and retained in the required quantities and durations to support investigations. Use to audit the retain sample program.
Out-of-Trend (OOT) Result Evaluation Checklist
Provides a structured approach to identify, evaluate, and respond to out-of-trend analytical or stability results that remain within specification but deviate from expected behavior. Use when defining or applying an OOT procedure.
DSCSA Serialization and Traceability Checklist
Confirms that a manufacturer or repackager meets Drug Supply Chain Security Act requirements for product identification, serialization, verification, and interoperable electronic tracing at the package level. Use to audit DSCSA readiness.
Combination Products cGMP Checklist (21 CFR Part 4)
Confirms that a drug-device or biologic-device combination product operates under a compliant streamlined cGMP approach integrating drug (211) and device (820) requirements. Use to audit combination product manufacturing.
Reference Standard Management Checklist
Confirms that primary and secondary (working) reference standards are qualified, characterized, stored, and controlled to ensure the reliability of analytical results. Use to audit a reference standard program.
Contract Manufacturer (CMO) Oversight Checklist
Confirms that outsourced manufacturing at a contract organization is governed by a quality agreement, ongoing performance oversight, and defined responsibilities between contract giver and acceptor. Use to audit CMO governance.
Container Closure Integrity Testing (CCIT) Checklist (USP <1207>)
Verifies that a container closure integrity testing program uses validated, appropriately sensitive methods to demonstrate that sterile product packaging maintains a barrier to microbial ingress and gas or liquid leakage. Use when establishing or reviewing a CCIT program.
GCP Clinical Site Monitoring Visit Checklist (ICH E6)
Structures a clinical research associate's on-site monitoring visit to verify subject protection, data integrity, and protocol compliance at an investigational site. Use for interim monitoring visits.
Equipment Qualification (IQ/OQ/PQ) Checklist
Verifies that manufacturing equipment is installed, operates, and performs as intended through Installation, Operational, and Performance Qualification. Use during equipment commissioning and requalification.
Analytical Method Validation Checklist (ICH Q2)
Confirms that an analytical procedure has been validated for its intended use with appropriate performance characteristics. Use when validating identification, assay, impurity, and dissolution methods.
Aseptic Gowning Qualification Checklist
Qualifies personnel to gown and behave aseptically for entry into Grade A/B cleanroom environments, including visual, microbial, and behavioral assessment. Use for initial qualification and periodic requalification.
Media Fill / Aseptic Process Simulation (APS) Checklist
Verifies that an aseptic process simulation is designed, executed, and evaluated to demonstrate the capability of the aseptic process. Use to plan and assess media fill runs.
GDP Cold-Chain Distribution Checklist
Confirms good distribution practice controls for temperature-sensitive medicinal products across storage, shipping, and receipt. Use to audit distribution operations and qualify cold-chain shipping lanes.
Pharmaceutical Water System Monitoring & Control Checklist (USP <1231>)
Assesses design, monitoring, and control of pharmaceutical water systems producing Purified Water and Water for Injection. Use for periodic system review and monitoring program verification.
Pharmacovigilance Adverse Event Reporting Checklist (ICH E2)
Verifies that individual case safety reports are captured, assessed, and submitted within regulatory timelines for post-marketing pharmacovigilance. Use for case processing quality review and PV system audit.
Technology Transfer Readiness Checklist (ICH Q10 / WHO TRS 961)
Assesses readiness to transfer a product and process between development and manufacturing or between sites, ensuring knowledge, methods, and validation are in place. Use for sending/receiving site transfer gating.
Environmental Monitoring Program Checklist (Viable & Non-Viable)
Evaluates the design and execution of a cleanroom environmental monitoring program covering viable and non-viable particulate, surface, and personnel monitoring. Use for EM program review and audit.
GxP Audit Trail Review Checklist
Verifies that audit trails in GxP computerized systems are enabled, complete, secure, and routinely reviewed as part of data integrity governance. Use for periodic audit trail review and CSV data-integrity assessment.
API / Excipient Supplier Audit Checklist
Guides an on-site or remote GMP audit of an active pharmaceutical ingredient or excipient supplier to support material qualification. Use for initial qualification and periodic requalification audits.
IND / IMPD Submission Readiness Checklist
Confirms that the quality, nonclinical, and clinical content required for an Investigational New Drug application or Investigational Medicinal Product Dossier is complete before submission. Use as a pre-submission gating review.
Process Performance Qualification (PPQ) Stage 2 Readiness Checklist
Confirms that a commercial manufacturing process is ready to enter Stage 2 Process Performance Qualification and that PPQ batches demonstrate reproducible, controlled performance. Use before executing and when reviewing PPQ campaigns.
Out-of-Specification (OOS) Investigation Checklist (FDA 2006 Guidance)
Guides a two-phase out-of-specification investigation for laboratory test results, from initial laboratory assessment through full-scale manufacturing investigation and disposition. Use whenever a result falls outside specification.
Annual Product Quality Review (APQR/PQR) Checklist
Structures the periodic (typically annual) review of a product's manufacturing and quality data to verify process consistency and identify improvements. Use to compile and approve the yearly product quality review.
21 CFR Part 11 Electronic Records & Signatures Compliance Checklist
Assesses whether a computerized system meets FDA requirements for trustworthy electronic records and legally binding electronic signatures. Use for closed/open system qualification and periodic review.
CAPA Management Checklist (21 CFR 820.100 / ISO 13485)
Verifies that corrective and preventive action records are properly investigated, actioned, verified for effectiveness, and closed. Use for CAPA file review and quality system audits.
Cleaning Validation Checklist (21 CFR 211.67 / ICH Q7)
Confirms that cleaning procedures for shared product-contact equipment are validated to prevent cross-contamination and carryover. Use during cleaning validation protocol review and requalification.
Computer System Validation (CSV/CSA) Checklist (GAMP 5)
Verifies that a GxP computerized system is validated using a risk-based, critical-thinking lifecycle per GAMP 5 and FDA Computer Software Assurance principles. Use for new system validation and periodic review.
CRO / Supplier Qualification & Oversight Checklist
Evaluates qualification and ongoing oversight of contract research organizations, contract manufacturers, and material suppliers. Use during vendor onboarding and periodic performance review.
Aseptic Processing & Sterile Manufacturing Checklist
Verifies environmental, personnel, and process controls for aseptic manufacturing of sterile drug products. Use for cleanroom readiness, batch review, and self-inspection.
Stability Program Checklist (ICH Q1A / 21 CFR 211.166)
Confirms the stability testing program supports expiration dating and storage conditions for drug products and substances. Use for stability protocol review and annual program assessment.
Complaint Handling & MDR Reporting Checklist (21 CFR 820.198 / Part 803)
Verifies complaint intake, evaluation, investigation, and Medical Device Reporting decisions and timelines. Use for complaint file review and post-market surveillance audits.
GMP Deviation Management Checklist (21 CFR 211.192)
Verifies that manufacturing deviations and discrepancies are captured, risk-assessed, investigated, and resolved before batch disposition. Use for deviation record review and QA oversight.
Change Control Management Checklist (ICH Q10)
Verifies that proposed changes to processes, equipment, materials, methods, or systems are evaluated, approved, and implemented under a controlled change management system. Use for change request review.
ISO 13485 QMS Internal Audit Checklist
Evaluates conformance of a medical device quality management system to ISO 13485:2016 across documentation, management, resources, realization, and improvement. Use for internal audits and certification readiness.
GLP Nonclinical Study Conduct Checklist (21 CFR 58)
Verifies that nonclinical safety studies are conducted under Good Laboratory Practice with proper study direction, protocol control, and QA oversight. Use for study file review and GLP facility inspection.
QMSR / 21 CFR 820 Transition Readiness Checklist
Assesses readiness for the FDA Quality Management System Regulation, which incorporates ISO 13485:2016 by reference effective February 2, 2026. Use to gap-assess a legacy QSR quality system against the QMSR.