We offer many GMP services which can help the clients across globe, ranging from audits to various consulting services. We provide comprehensive, hands-on GMP Quality Compliance services to the pharmaceutical industry ranging from audits to various consulting services.
We frequently perform GMP audits at a various supplier sites across the globe to ensure GMP compliance.
We provide services for GMP Upgradation in compliance with guidelines USFDA, EMA, WHO, PICS.
We provide an integrated solution for GMP Compliance & Upgradation tailored to your needs at low costs in a time-efficient manner by:
Identify the technical and economic feasibility of Plant Set – Up project by conducting a feasibility as per GMP guidelines, to develop basic and detailed engineering.
We provide one or two solutions that emerge as the most suitable in the previous phase with design details including field studies, especially of a topographical, geological, geotechnical, hydrological and hydraulic nature.
We provide all the construction details by discipline (Civil, Mechanical, Process, Electric, Telecommunications, Instrumentation and Control, Computer Systems) which is needed /must be approved for construction.
We assist in procurement of all types of Equipment, Utilities, Change Parts & Clean Room Panels etc. as per URS/BOQ/ Tender Documents
We offer services for GMP-compliant Commissioning & Qualification of all equipment, Utilities & facilities as well as Validation to ensure reproducible Processes for Production, Cleaning, Analytic Methods and Computer Systems.
We serve all your validation requirements from project management to report writing that is from URS, FRS, DQ, FAT, SAT, Commissioning documents, VMP, IQ, OQ, PQ, PV to Validation report writing.
We cover different pieces of entire product management cycle as customized services.
Pharma Plant Set-Up: We have extensive experience for complete setup of pharmaceutical manufacturing unit which include IV fluids, Injectable, Tablet, Capsule, Liquid orals, Liquid externals, Powders, Bulk drugs, Liquid oral plants, Ointment/ Cream/ Lotions manufacturing plants.
QP Services: Include services like Product Release, Permanent / Short Term QP Cover , Quality System Review & Implementation, Risk Management, Supplier Assessment Review & Management, API / Formulation QP Audits & Certification
Sourcing: We help in procurement of best quality of Raw Materials, Packing Materials & Finished Goods through our experience at competitive price from established manufacturers /trading houses.
Training: Our qualified & experienced Trainers provide training on all GXP topics GMP, GDP, GLP, Data Integrity, Regulatory Affairs, QMS, Auditor Qualification and many other topics which enhance your employees and operational performance while mitigating compliance and business risks. Training agenda for each topic are customized based on experience of participants.
Regulatory: Our Regulatory experts provide CTD/eCTD Dossier Compilation & Submission, User Testing & Medical Writing services.
Contract Manufacturing: Emergence of India as a world-player in Pharmaceuticals has brought foreign companies the opportunity to outsource part of their production to Indian manufacturers, thus cutting costs & production hassles. We consult companies, both Indian and foreign on their contracting requirements.
Business & Marketing: Providing businesses at all stages with expert consultancy on how to strategically position & promote themselves, their products and services in order to tap into new markets, attract new customers, increase sales and ultimately increase profit.
In general, GMP monitoring (on-site monitoring of manufacturing process) depends on manufacturing process time period and expectations i.e. only monitoring of critical processes. Following activities shall be monitored at manufacturer site:
With extensive experience of our experts, pharmazone can contribute to Quality consulting and upgradation of any manufacturing sites. We can offer as following: