HVAC Validation in Pharma HVAC Validation = Control + Evidence + Compliance 1. DQ – Design QualificationVerify HVAC design meets GMP, process, room classification & user requirements. 2. IQ – Installation QualificationConfirm equipment, ducts, filters, sensors, controls and utilities are installed as per approved specifications. 3. OQ – Operational QualificationChallenge and verify HVAC operation under … Read more
AHU / CLEANROOM REQUALIFICATION Reference: ISO 14644-3:2019 + ISO 14644-2:2015 Objective: To verify that the AHU/cleanroom continues to maintain the required air cleanliness and environmental conditions during operation. ISO 14644-3 provides the applicable cleanroom test methods, while ISO 14644-2 establishes the monitoring/periodic-testing framework. KEY REQUALIFICATION TESTS Airflow Volume / Velocity→ Verify supply airflow and required … Read more
Sticky Notes for Pharmaceutical QMS (Quality Management System) Practical sticky notes for a pharmaceutical Quality Assurance (QA) department. You can print them or display them near workstations, laboratories, production areas, and document-control desks. 1. Daily QMS Reminders NOTE 1 — GMP Compliance “DO IT RIGHT. DOCUMENT IT RIGHT.” Follow approved SOPs. Never bypass an approved … Read more
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CAPA Effectiveness in the Pharma Industry Repeated Environmental Monitoring Excursions Scenario: During routine environmental monitoring of a Grade C manufacturing area, repeated excursions in microbial counts are observed at a specific monitoring location. Initial Observation – Over three months: Multiple microbial excursions occurred at the same location. Initial investigations focused primarily on cleaning and operator practices. … Read more
Pharmaceutical Change Control: GMP Process, Risk Assessment & Implementation Pharmaceutical Change: HVAC and Environmental Control 1. Proposed Pharmaceutical Change: Replace and upgrade an existing HVAC system serving a Grade C manufacturing area to improve temperature, relative humidity, pressure differential, air-change performance, and overall environmental control. Reason for This Pharmaceutical Change: The existing HVAC system is … Read more
Quality by Design (QbD) Framework for tablet manufacturing, covering Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), their relationship, and a practical risk assessment. 1. Tablet Manufacturing – Critical Quality Attributes (CQAs) CQAs are physical, chemical, microbiological, or performance characteristics that must remain within an appropriate limit/range to ensure the finished tablet meets its intended … Read more
EMPLOYEE JOINING & INDUCTION 1. PURPOSE To establish a controlled and consistent procedure for the joining, onboarding, orientation, induction, qualification, and initial training of newly hired employees so that each employee: Is formally and accurately onboarded; Understands the organization’s expectations, responsibilities, and workplace requirements; Receives the information and training necessary to perform assigned duties; Understands … Read more
RECRUITMENT & SELECTION POLICY 1. PURPOSE The purpose of this policy is to establish a fair, consistent, documented, competency-based, and legally compliant recruitment and selection process for hiring qualified personnel. The policy ensures that the organization recruits individuals whose education, training, experience, technical knowledge, skills, and competencies are appropriate for their assigned responsibilities. For pharmaceutical … Read more