TEMPERATURE MAPPING

Temperature mapping – we have the expertise and equipment to perform temperature mapping of your warehouses, cold rooms and other temperature-controlled spaces.

From the smallest bench top oven, to the largest sterilizer, (and everything in between), QACAL can put a package in place which will not only meet your validation requirements, but exceed your expectations!!

If you already have a validation protocol in place, then we can execute it for you. However if necessary, we can help to draw up a protocol which suits your specific application.

Temperature mapping experience includes :

• Autoclaves
• Coolers
• Cryogenic Freezers
• Depyrogenation Ovens
• Dry Heat Ovens
• Freezers
• Incubators

  • Portable Storage Units
  • Clean in place (CIP)
  • Steam in place (SIP)

 

• Lyophilizers
• Ovens
• Refrigerators
• Stability Chambers
• Ultra Low Temperature (ULT) Freezers
• Vacuum Ovens

 

Master Instruments List for Temperature Mapping

Sr. No.

Instrument Name

Make/Model

Range

Accuracy

Qty

1

DATA LOGGER

EUROTHERM DEL INDIA LTD/6180V.

PT 100 (-200 to 850°C)

±0.01°C

2

2

DATA LOGGER

EUROTHERM DEL INDIA LTD./6180A-U48

PT 100 (-200 to 850°C)

±0.01°C

1

3

DATA LOGGER

YOKOGAWA INDIA LTD./MV1024-1-4-2-2-3F

PT 100 (-200 to 850°C)

±0.15% of rdg + 0.3°C

2

4

DATA LOGGER

YOKOGAWA INDIA LTD./MV2040-1-4-2-2-1F

PT 100 (-200 to 850°C)

±0.15% of rdg + 0.3°C

2

 

GMP CONSULTING

GMP Compliance Audits

GMP Compliance Consulting
We have an international client base covering Gulf countries, South East Asia and India. We are flexible and responsive to meet your specific needs.
Our GMP compliance consultancy services include:

  • Setting up GMP- compliant Quality Assurance systems
  • Supplier audits
  • Interim management
  • Staff training

We have particular experience in handling active pharmaceutical ingredient (API) audits.

GMP- Compliant Quality Assurance Systems

GMP technical solutions help companies to set up GMP-compliant quality assurance systems that are appropriate to their needs.  We provide a range of services to ensure that you and your contractors meet EU and FDA Good Manufacturing Practice requirements, including:

  • Preparation of Standard Operating Procedures
  • Preparation of Validation Master Plans
  • Preparation of Site Master Files
  • Staff training
  • CAPA
  • Technical/Quality Agreements

Our expertise covers Active Pharmaceutical Ingredients, Investigational Medicinal Products, sterile and non-sterile dosage forms and biotechnology products.

Complaince Audits
We can audit any type of activity against all the major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more.

Complaince Audits.

  • Audits of companies wishing to import products into different countries
  • Pre-audits in preparation for competent authority (eg EMEA, MHRA, FDA) inspections
  • Design and management of corrective action plans
  • Oral solid dosage manufactures
  • Liquid manufactures
  • Topical manufactures. (WHD & LOCAL SCHEDULE M GUIDELINES)
  • Audits for medical devices manufactures as per ISO 13485
  • ETO sterilization unit
  • Gamma Irradiation unit