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
HR (HUMAN RESOURCES) POLICIES & STANDARD OPERATING PROCEDURES 1. Purpose The purpose of this HR Policy and SOP framework is to establish a consistent, transparent, compliant, and documented system for managing employees throughout their employment lifecycle. The system shall ensure that personnel are: Qualified for their assigned responsibilities. Adequately trained before performing GMP-related activities. Aware of … Read more
Quality Risk Management for New Products, Processes, Equipment, Facilities, Technology Transfer and Scale-Up Introducing a new pharmaceutical product, manufacturing process, equipment, facility modification, technology transfer, scale-up activity, or process change can create significant quality risks. A change that appears technically simple may affect: Critical Quality Attributes (CQAs) Critical Process Parameters (CPPs) Material attributes Process capability … Read more
Pharmaceutical eQMS & Digitalization FDA Compliance: A Practical Guide for FDA-Regulated Companies Digital transformation is changing how pharmaceutical companies manage quality, compliance, documentation, and operational risk. For many years, pharmaceutical Quality Assurance departments relied heavily on paper-based systems, spreadsheets, email approvals, and manually maintained quality records. While these approaches can support basic operations, they can … Read more
Continual Improvement of the Pharmaceutical Quality System: A Practical FDA, ICH & PIC/S Framework A pharmaceutical quality system should do more than demonstrate compliance. It should enable an organization to identify emerging risks, understand process performance, learn from quality events, and continuously improve its operations. For pharmaceutical manufacturers supplying the United States, continual improvement should … Read more
EYE/EAR DROPS S.no GENERIC NAME COMPOSTION REF . CLAIM STRENGTH 1. Atropine Sulphate Ophthalmic Solution IP Composition: Atropine Sulphate IP 1%, w/v Phenyl Mercuric Nitrate (As Preservative) IP 0.001% w/v Sterile Aqueous Base q.s 2. Atropine sulphate ophthalmic solution IP Composition: Atropine sulphate IP 0.01%&0.05% w/v StabilisedOxychloro Complex (As Preservative) 0.005% v/v Sterile Aqueous … Read more
LIQUID INJECTION S.no. GENERIC NAME COMPOSITION REF. CLAIM STRENGTH 1 AmikacinSulphate Injection IP 100 Mg/2ml 250mg/2ml 500mg/2ml Each 2ml contains: AmikacinSulphate Eq. to Amikacin IP 100,250,500 mg Methyl Paraben (As Preservative) IP 0.18% w/v Propyl Paraben (As Preservative) IP 0.02% w/v Water For Injection IP q.s. 2 Aceclofenac Injection Each ml contains: … Read more
DRY INJECTION (HUMAN) S.NO GENERIC NAME COMPOSITION REF. CLAIM STREN. 1 Acyclovir Intravenous Infusion IP (250 mg)(500mg) Each Vial Contains: Acyclovir Sodium (Sterile) Eq. to Anhydrous Acyclovir IP 250 & 500 mg 2 Artesunate Injection IP 60 & 120 &90 &180 Each Vial Contains: Sterile Artesunate IP 60 & 120 &90 &180 mg 3 Amoxycillin … Read more