We provide expertise in Quality Control Testing, Method Development, Validation, comparative dissolution and Stability Storage facility and Testing of pharmaceutical raw materials and finished products at state of the art GMP complaint facility. Prime Health is providing independent, contract analytical services to the global pharmaceutical and related industries.
PRIME HEALTH
Pakistan’s 1st Laboratory to offer Customer Specific Contract Services
Our modern facilities and state-of-the-art equipment allow reliable, reproducible analysis, whether you need routine Quality Control Analysis, method development, generic product development or water testing, Prime Health has the expertise and resources to serve your needs.
News & Alerts:
11th to 13th February 2020
Prime Health Pvt Ltd Participated, in PPE – Pak Pharma & Healthcare Expo held in Expo Centre Lahore Pakistan.
January 22, 2020
WHO Prequalification Inspection
A two-member team from WHO HO Geneva conducted a three (03) day inspection for Prequalification from 22nd January to 24th January 2020.
The scope of the inspection was limited to the activities of the drug physicochemical laboratory with the inspection covering under the sections of the WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL).
July 10, 2019
Prime Health Pvt Ltd Participation, in PPE – Pak Pharma & Healthcare Expo to be held in Pak China Friendship Center Islamabad on 10 – 11th July 2019. visit us at Stall # F-3
September 28, 2018
DRAP (Drug Regulatory Authority of Pakistan) has successfully inspected Prime Health Pvt Ltd as the 1st GMP compliant contract laboratory in Pakistan to perform test & analysis on pharmaceutical drug substances & products.
Inaugural Ceremony of Prime Health Laboratories on 10th August, 2018 at 7:00 pm Ballroom A, Movenpick Hotel, Karachi.
Laboratory Services
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Pharmaceutical Equivalence Studies
Pharmaceutical equivalence studies (Comparative dissolution profile) is an important step towards the confirmation of similarity and interchangeability among pharmaceutical products, particularly regarding those that will not be tested for bioequivalence. At Prime Health comparison of therapeutic performances of two medicinal products containing the same active substance will help assessing the possibility of alternative using between the innovator and any essentially similar medicinal product.
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Raw Material Testing
Prime Health raw material testing will help provide purity, contamination, Residual Solvents and material testing services, for a variety of raw materials. Raw material quality control is necessary to prevent product failure and ensure a consistent level of quality, as well as safety in consumer and industrial products.
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Stability studies
Stability testing (Using stability indicating methods) at Prime Health Lab will help to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such as temperature, humidity and light. Stability Storage is structured as multiple chambers, which are designed to meet various temperature conditions, required by FDA and ICH, as well as other conditions required specifically by the client. All of storage chambers are continuously monitored by a computerized system, with temperature and humidity set-point windows at ±2° C and ±5°RH.
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Pharmaceutical Finished Product testing
Finished product testing will be performed as per guidelines by FDA. All finished products must be tested prior to distribution. The tests that are performed will ensure that the product meets established specifications and that these specifications account for its purity, integrity, efficacy, and concentration. The tests can include titrations, Spectrophotometer, pH, conductivity, HPLC, GC, AA, and others.
“QUALITY OUR PRIORITY”
Prime Health aims to focus on following core strengths to provide excellence in product testing:
- Superior Service
- Fast, reliable results
- Uncompromising Integrity
- State-of the-art equipment & instrumentation
- Highly skilled staff
- Education & Training
- Focused, continued commitment to the highest quality standards
FACILITIES & TECHNOLOGIES
- cGMP compliant laboratory design
- Sophisticated German Laboratory Furniture made from corrosion-resistant and wear-resistant materials
- LIMS – Laboratory Information Management System: for traceable & accurate results and data integrity
- Adequate stability storage capacity for conducting stability studies by using validated stability-indicating analytical methods under ICH guidelines
- Highly sophisticated analytical instruments with 21 CFR part 11 compliant software
QUALITY MANAGEMENT SYSTEM (QMS)
An independent Quality Assurance unit comprising of trained & experienced professionals with analytical, quality assurance and regulatory compliance expertise will be committed to Prime Health’s Quality Management System (QMS) & Accreditations
Copyright © 2018 Prime Health Laboratories Inc. All rights reserved.