SOPs & Pharma Documentations Preparation, QA Trainer and GMP Implementation With

Active Pharma Consultant

Better Calibration & Industrial Automation Services

Scope of Active Pharma Consultant

CALIBRATION SCOPE



  • Various types Instruments calibration as regulatory requirement and cover to all parameters of pharmaceuticals, chemical/ agrochemical industries.
  • Active Pharma consultant (APC) is one of the leading Calibrations & Validation Laboratory in India located at Bharuch, Gujarat
  • APC is an ISO 9001: 2015 (Quality Management System) Certified Company
  • APC is providing Calibration & Validation services to many different industries like Pharmaceutical, Chemical, Engineering, Biosciences and Plastic etc. from all around the world
  • APC has vast scope for different types of calibration instruments like Pressure and Vacuum Gauge, Temperature and Relative Humidity, Flow, Level, Revolution, Time Inverter, Mass, Volume, Electrical, Dimensional, Laboratory Instruments And Other types of Instruments
  • APC is providing Calibration services to customers in either our own environmentally controlled facility or on customer site facility
  • APC is equipped with high standard and precise calibration equipment / reference standard instrument from the reputed National / International manufacturers
  • Standard instruments of APC are traceable to national / international standard through accredited laboratories (NABL)
  • Calibration / Validation procedures of APC are in accordance with national / international standard like ISO / IEC 17025 (NABL) for instrument calibration and EN-285, HTM-2010 for equipment validation
  • Technical team is highly qualified & trained with sound experience in service sector who really understand the philosophy of service business
  • Calibration & Validation Reports are acceptable for USFDA, MHRA, WHO, TGA, EDQM, ISO and other audits
  • Takes annual contracts to provide uninterrupted service

Thermal Validation

  • Industrial Furnaces
  • Cold rooms
  • Incubator/ovens
  • Storage area/cabinet/system
  • Warehouse
  • Stability Chambers
  • Refrigerators
  • Deep freezer
  • Tunnels
  • Tray Dryers
  • Pharma manufacturing areas
  • Autoclaves
  • Water Baths

HVAC Validation

  • Pressure Balancing Test
  • Particles Count Test
  • HEPA Filters Integrity Test
  • Air Velocity Test
  • Area Recovery Test
  • DP Monitoring
  • Smoke study
  • Air Changes Test
  • Compress Air Validation

Validation & Mapping Details

  • Validation will be carried out with Software Based PC Interface Data Logger (21 CFR Part 11 Compliance).
  • Validation Report having details like Pass Criteria, Procedure, Drawing, Min. / Max. / Average for Each Point Temperature, Graph, Lethal Rate & F0 and FH Value Calculation, Hot Point, Cold Point and Conclusion etc. (Also add other details required by customers).
  • Temperature Mapping Report having details like Pass Criteria, Procedure, Drawing, Min. / Max. / Average for each point temperature, Graph, Hot Point, Cold Point and Conclusion etc. (Also add other details required by customers).
  • Validation & Temperature Mapping Report complies with major Regulatory Body like USFDA, MHRA, WHO, TGA, EDQM etc.

GMP CONSULTANT & PHARMA DOCUMENTATION SCOPE

  • Helping hands for preparation of GMP related documents for growing company.
  • Quick support for compliance of Audit observations
  • Preparation of all the Pharma documents like SOPs, Site Master File (SMF), Validation Master Plan (VMP), Quality Manual, Stability & Hold Time Study Protocol & Report, Process Validation, Cleaning Validation, Equipment Qualification, Water system & HVAC Qualification Training related documents, Nitrosamine Impurity Risk Assessment, Instrument calibration, Equipment Usage Logs and other logbooks, Computer System Validation, Temperature Mapping of Equipment & Area Protocol & Reports etc.
  • Pre-audit before Regulatory Audit
  • Regulatory Audit Support
  • Vendor Qualification Support
  • Analytical Method Validation & Computer System Validation Support
  • On site SOP preparation and actual implementation

Active Pharma Consultants

Our Active pharma consultants team has been providing below faculties

  • Various types Instruments Calibration Services in the pharmaceutical as well as chemicals and agro chemicals industries.
  • Provide practical demo of instruments Calibration/ Maintenance/ Troubleshooting /Configuration and give a practical demo training on the various type instruments.
  • Fully Industrial Automation Training (i.e. various types PLC’s programming, SCADA) with practical training at industries side placement.
  • Industrial Pharma Documentation & Quality Assurance Training.

Happy Clients

Projects

Hours Of Support

Hard Workers

Active Pharma Consultant Expertise Lies in

  • Calibration Scope: We are providing highly sophisticated calibration in the various parameters. Each and every calibration are performed are backed up with National/International Traceable Reference Standards which further involves highly expertise workman.
  • Validation Scope: We offer accurate validation services for Temperature and Humidity relative. Let it be Cold room, an Incubators or even a ware house, an Autoclave. We have a solution to find out your Temperature and Humidity relative distribution
  • Temperature & Relative Humidity Mapping of Equipment / Area
  • GMP Consultant and preparation of QMS Documentation in the pharmaceuticals Industries
  • Industrial Automation Training (Various Types PLCs, SCADA, HMI, VFDs with provide practical Training) with fully industrial practical training in the minimum days
  • Practical Training demo on Industrial Process Measurement & Control
  • Practical Industrial Training on Pharma Documentation & Quality Assurance
  • Various types Instrument Supplier

Instruments Calibration Services

  • 1. Provide calibration to various type Instruments in the industries.
  • 2. Provide Validation and Temperature mapping in the Pharmaceutical Industries.
  • 3. Provide Quality Assurance and pharma Good Documentation practical training as per cGMP.
  • 4. Provide Consultant Service as Quality Assurance in the Pharmaceutical Industries.
  • 5. Provide Industrial Automation Training on the various PLCs, VFDs, SCADA , HMI systems.
  • 6. Provide Computer System Validation and Certification as per 21 CFR Part 11.

Software Validation

  • Software validation and certifications as per 21 CFR part 11
  • PLC Qualification
  • SCADA Qualification
  • HMI Qualification

Industrial Process Measurement & Control

  • This training program provides overview of industrial measurement and control system and practical approach to field instruments.

PLC, SCADA & Distributed DAS

  • This training program provides demo training as well as provide a practical training at side on the most popular PLCs, SCADA software and Distributed DAS system
  • This course covers all aspects of automation as well as integration of different hardware and software
  • After completion of this course you will be in a position to design, program, commission and troubleshoot an automation system
  • This training program provides in depth knowledge about field Instrumentation, Panel Designing, Programmable Logic Controllers, Variable Speed Drives, Supervisory Control & Data Acquisition Software and DCS Basics
  • After completion of this course you will be able to design program & commission total automation solution which includes transmitter, drives, PLCs and SCADA systems

Benefits of our Automation Training

  • Get full practical training from our experts at industries side and develop
  • Provide automation training until get expertise in the automation related system
  • After completion of training, candidate feel own self like experiences person
  • Our team conducts to exam after a completion of course and provides a certificate to the students who have pass the exam. If any student not pass the exam, again team provide additional training free of cost and again conduct the exam with certified
  • Provide placement to suitable candidates in the industries
  • Provide automation training certificates

INDUSTRIAL PHARMA DOCUMENTATION & QUALITY ASSURANCE TRAINING

  • Provide training on basic Pharma Guideline like ICH, USFDA, EDQM, APIC etc. and Quality Management System
  • Provide training on preparation and review of Standard Operating Procedure (SOP) of Quality Assurance, Quality Control, HR & A, Engineering, Production etc..
  • Provide training on preparation documents like Site Master File (SMF), Validation Master Plan (VMP), and Quality Manual (QM).
  • Provide training on preparation documents like Stability & Hold Time Study Protocol & Report, Process Validation, Cleaning Validation, Equipment Qualification, Water system & HVAC Qualification, Nitrosamine Impurity Risk Assessment, Instrument calibration, Temperature Mapping of Equipment & Area Protocol & Reports etc
  • Provide training on preparation of Audit Compliance Report.
  • Provide placement to suitable candidates in the industries
  • Provide Quality Assurance training certificates.

Accreditations

We are certified by ISO 9001:2015 (Certificate No. QMS/030553/1022)

100% Placement Oriented

We Provide 100% placement in following field

Mr. Chirag Patel (M. Pharm)

Owner

He has more than 10 years of experience in APIs and Formulations pharmaceutical companies. He is overall responsible for Quality Activities.

Mr. Chirag Raiyani (M. Sc.)

Managing Director

He has more than 12 years of experience in Intermediate, APIs, Formulations and Parenteral / Injectable Pharmaceutical companies. He is overall responsible for Project and Quality Complies Activities.

Mr. D. Patel (Technical Engineer)

Technical Director

He has 10 years of experience in Automation, Instrumentation, Temperature mapping, Calibration of measuring devices, PLC Calibration, HVAC validation related activities. We are provide Instruments / PlCs, SCADA ,DCS Automation related solutions.

Mr. Dhaval Chovatiya (Technical Engineer)

Technical Director

He has 8 years of experience in Automation implementation related activities in various industries like Pharmaceutical, Chemical, Food, Bioscience and Engineering. He has work as a automation trainer. Provide automation solutions in the various type PLCs, SCADA, DCS system.

Team

Mr. Chirag Patel (M. Pharm)

Owner

Mr. Chirag Raiyani (M. Sc.)

Managing Director

Mr. Dhaval Chovatiya (Technical Engineer)

Technical Director

Mr. D. Patel (Technical Engineer)

Technical Director

Contact

Our Address

House No.158, Maharshi Bungalow, Near Zadeshwar Cross Road, Bharuch - 392 001, Gujarat, India