Pharmaceutical eQMS Digitalization FDA Compliance

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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

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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 

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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

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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

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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

COPP LIST – Lyophilized Injection

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COPP LIST – Lyophilized Injection S. No Generic Name COPP 1 Voriconazole for Injection 200mg/vial (Lyophilized)   2 Cerebroprotein Hydrolysate for Injection 60mg (Lyophilized) Available 3 Caspofungin Acetate for Injection 70mg (Lyophilized) Available 4 Caspofungin Acetate for Injection 50mg (Lyophilized) Available 5 Vecuronium Bromide for Injection BP 10mg/vial (Lyophilized) Available 6 Pantoprazole for Injection BP … Read more

COPP LIST – Liquid Ampoule Injection

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COPP LIST – Liquid Ampoule Injection S. No Generic Name COPP 1 Diclofenac Sodium Injection 75mg/ml Available 2 Diclofenac Sodium Injection 25mg/ml Available 3 Citicoline Sodium Injection 250mg/ml Available 4 Artemether Injection 40mg/ml Available 5 Artemether Injection 80mg/ml Available 6 Atracurium Besylate Injection USP 25mg/2.5ml Available 7 Atracurium Besylate Injection USP 50mg/5ml Available 8 Clindamycin … Read more

COPP LIST – Liquid Vial Injection

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COPP LIST – Liquid Vial Injection S.No Generic Name COPP 35. Amikacin Sulfate Injection USP 500mg/2ml Available 36. Lidocaine Injection USP 20mg/ml Available 37. Amikacin Sulfate Injection USP 100mg/2ml Available 38. Amikacin Sulfate Injection USP 250mg/2ml Available 39. Ascorbic Acid Injection USP 250mg/ml Available 40. Rocuronium Bromide Injection 50mg/5ml Available 41. Dexamethasone Injection USP 4mg/ml … Read more

COPP LIST – Dry Powder for Injection

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COPP LIST – Dry Powder for Injection S.No Generic Name COPP 1. Pantoprazole for Injection BP 40mg Available 2. Acyclovir for Injection USP 250mg Available 3. Acyclovir for Injection USP 500mg Available 4. Creatine Phosphate Sodium for Injection (Combipack) Available 5. Teicoplanin for Injection 200mg Available 6. Teicoplanin for Injection 400mg Available 7. Methylprednisolone Sodium … Read more

Pharmaceutical Facility

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Pharmaceutical Facility Management A pharmaceutical facility is a GMP-compliant manufacturing, testing, packaging, warehousing, and distribution environment designed to ensure that pharmaceutical products are consistently produced and controlled according to predefined quality standards. The facility must be designed, constructed, qualified, operated, maintained, and monitored to prevent contamination, mix-ups, cross-contamination, and errors while ensuring compliance with regulatory … Read more