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GMP SERVICES

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.

GMP AUDITS

Types of Audit
  • QMS Audit: Review in view of compliance and efficiency
  • Root Cause Audit: to investigate a process/Lab failure and CAPA
  • GAP Audit: Checking of all  GMP systems, QMS, Infrastructure, Resources
  • Vendor Audit: Vendor Qualification or Re-qualification Audit
  • Pre-inspection GAP/Mock Audit: Just before Inspections  are scheduled.
  • Sponsored Audits: Audit done on behalf of Sponsor

 

Independent GMP Qualification Audit Program (IGQAP)

We frequently perform GMP audits at a various supplier sites across the globe to ensure GMP compliance.

  • We carry out various audits including full Site audits which focus on the facility’s quality management systems and cover a large number of products (API and Intermediates).
  • The GMP audits are conducted by our qualified and experienced auditors at no charge to the supplier, every 3 years. With permission of the supplier, we add the IGQAP report to our report library.
  • By purchasing our IGQAP reports from library, our clients only spend a small fraction of the costs usually associated with conducting a supplier audit.
  • With this huge experience, you can rely on us to take complex compliance issues to conclusion.
  • Our commissioned audits and audit partnership services can minimize the cost of the audit and ensure that our clients receive personalized reports with areas most relevant to their operations.

Audits Reports

Ami Organics
Surat
Gujarat
Amoli Organics
Vadodara
Gujarat
Anhui Haikang
Daguan
Anqoing Anhui
Aurobindo Unit III
Polepally
Andhrapradesh
Aurobindo Unit VII
Bachupally
Telangana
Aurobindo Unit VIII
Gaddapotharam
Andhrapradesh
Azico Biophore
Vishakhapatnam
Andhrapradesh
Brightgene Pharmaceuticals
Suzhou
Jiangsu
Cipla Unit VII
Verna
Goa
Cipla D-7
Kurkumbh
Pune
Crystal Pharma
Valladolid
Spain
Dr. Reddy's Lab Unit VII
Bollaram
Andhrapradesh
FarmaBios SPA
Cairoli
Italy
FIS
Vicenza
Italy
Formosa Lab Inc
Taoyuan
Taiwan
Granules India
Jeedimetla
Telagana
Guan Peking
Langfang
Hebei
Harman Finochem
Chikalthana
Maharashtra
Hebei Jiheng Pharmaceuticals
Hengshui
Hebei
Jiangxi Dongbang
Fengxin
Jiangxi
Joyang Laboratories
Yancheng
Jiangsu
Jubilant Generics
Nanjangud
Karnataka
Maithri Laboratories
Bonthapally
Telangana
Megafine Pharma
Nashik
Maharashtra
Morepen Laboratories
Solan
Himachalpradesh
MSN Laboratories
Rudram
Telangana
MSN Lifesciences
Chandampet
Telangana
MSN Pharmchem
Pashamylaram
Telangana
Neuland Laboratories
Bonthapally
Telangana
Shilpa Medicare
Raichur
Karnataka
Shriji Polymers
Ujjain
Madhyapradesh
Sirio Healthcare
Ma’anshan
Anhui
SMS Pharmaceuticals (unit-I)
Kazipalli
Telangana
Symbiotec Pharmalab
Pithampur
Madhyapradesh
Vasudha Pharmchem
Visakhapatnam
Andhrapradesh
YungZip Chemical
Taichung
Taiwan
Zhejiang Huahai
Linhai
Zhejiang

Compliance and Upgradation

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:

 

  • Establishing GMP Management Systems
  • Performing the Gap Analysis
  • Planning Activity as per Guidelines
  • Guidance in Implementation & Documentation
  • Training Activities for Executives
  • Conducting Internal Audits

Engineering

We offer the engineering services to cover complete range from Conceptualization till Validation.
Conceptual Engineering

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.

Basic 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.

Detailed Engineering

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.

Procurement

We assist in procurement of all types of Equipment, Utilities, Change Parts & Clean Room Panels etc. as per URS/BOQ/ Tender Documents

Commissioning & Qualification

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.

Validation

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.

GMP Consulting

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.

GMP Monitoring

audit

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:

  • Dispensing of raw materials, Packaging Material and Review of Analytical data of all Raw Materials
  • Monitoring of Production activities for manufacturing of various formulations.
  • Ensure that batches shall be executed as per the Batch records/SOP.
  • Review of all investigations, Deviations and Change controls pertaining to the batch/batches.
  • Ensure that all manufacturing and analytical equipment used in batch manufacturing are adequately qualified, Calibrated and in the good state of Maintenance.
  • Review of electronic data, Audit trail records of analytical equipment, working standards qualification records.

Quality Consulting

With extensive experience of our experts, pharmazone can contribute to Quality consulting and upgradation of any manufacturing sites. We can offer as following:
 

  • Quality Systems components assessment, such as internal SOPs, specifications, change control, trend analysis, input inspection, outsourced operations control, and personnel development
  • CAPA programs assessment