Our Science

Quality is way of life at PRISCA sciences. Quality is our strength and in order to maintain it at every stage of our activity, we have an In-House QA Department. We have designed and developed our Quality Assurance System which encompasses all applicable elements of ICH Q7. The procedures & controls are in place from Manufacturer’s qualification to Order Execution. We have an agreement with Government Approved Testing Laboratories wellequipped with all necessary instruments and highly qualified technical

Due to company’s aspiration in supplying high quality products, the company associates itself with Manufacturers who comply with the WHOGMP norms set by the various international guidelines like; ICH Q7/21 CFR 210,211. These norms are verified by periodic evaluation of Manufacturer’s Quality Assurance System.

At Prisca we strive to provide customers with quality products that exceed their expectations.

Regulatory Services

Our in house regulatory services includes a team of professionals, with significant experience in Pharma Sector. The team manages regulatory submissions & amendments; communications with Regulatory Agencies (USFDA, EU MS, PMDA, KFDA etc.) with a strong track record in dealing variations, requests, enquiries, onsite, pre-approval inspections and renewal inspections by respective agencies.

Our Services include: NDAs, INDs, DMFs, ANDAs, MAAs and other regulatory submissions.

  • Pre-Registration Services
  • Registration Services
  • Post-Marketing Services
  • Specialty Services – Technical
  • Specialty Services – Operational

Quality Assurance

  • Adherence to Quality Agreements:

    PRISCA believes in long term association with its business partners. In order to maintain the clarity in the Quality attribute requirements PRISCA enters into Quality Agreement with its partners and ensures that the requirements of the Quality Agreements are fulfilled at all the time.

  • Supplier Qualifications:

    In our endeavor to meet customer quality requirements we select our suppliers with utmost care to ensure that the supplier is capable of consistently supplying right quality products. We follow a well-defined Supplier Qualification process which includes Supplier Self-Assessment, Pre and Post Approval Quality Audits and Periodic Qualification. The entire process of Supplier Qualification is carried out in concurrence with customer.

  • Stringent and Systematic controls on product release:

    For PRISCA objective is to consistently supply right quality products to the customers. We exercise additional control to meet our objectives. After product is approved by manufacturer, PRISCA’s personnel visit the site of manufacturer who is well trained to inspect & check the consignment as well as sample the product. The inspection is carried out as per predetermined checklist which includes Storage Conditions, Inspection of Containers, Labels, Lids, Closers, etc. PRISCA’s personnel prepares batch wise composite samples in 3 sets wherein 1st sample is sent to customer for pre-shipment sample evaluation, 2nd set of sample sent to testing laboratories to ensure the results are matching with customer’s specification & 3rd set of sample is kept with PRISCA as reserve sample for future purpose. The containers are sealed and the consignment is secured by isolating. Once the approval is received from the testing Laboratories and Customer, the consignment is re-inspected for the damage to the Containers, Labels or Seals and the Certificate of Analysis is prepared. After the final inspection the consignment is dispatched along Certificate of Analysis and all other regulatory and statutory documentation.

  • Warehousing Management:

    Storage of product is one of the critical activities in the Supply Chain Management. To avoid mix-ups and loss of product identity or purity, we exercise controls from product receipt, storage, and dispatch with the aid of various checklists. Product requiring special storage conditions are stored as per requirements and records are maintained for the same. PRISCA personnel confirm storage conditions when they go for sampling to the manufacturer’s premises.

  • Traceability of Distributed APIs and Intermediates:

    Traceability of the products is very important in case of any eventuality. We retain all product consignment related documents like; Certificate of Analysis, transportation documents, statutory and regulatory documents, all inspection checklists and any other related document as per the regulatory guidelines.

  • Information Management:

    Our Quality Agreements stipulate the requirement of Quality and Regulatory information to be shared with the customer. Some of the information like; Process Description, Specification, Test Methods, Labeling requirements, etc. are shared before start of the business and are updated as and when needed. The batch wise information like; Certificate of Analysis, packing list, etc. is provided along with each consignment.

  • Compliance Management:

    Quality Assurance Department is responsible for management of Customer Complaint. PRISCA aims for ZERO Customer Complaint and puts in all its’ efforts to achieve it. In spite of all our efforts, if we receive any Customer Complaint, we manage it with a defined procedure. When we receive the complaint, we register and review the nature of the complaint. If complaint is Quality or Quantity related then the details are passed on to Manufacturer for the Root Cause Analysis and Corrective / Preventive Action. Logistic and Commercial complaints are investigated at PRISCA. Once the Root Cause is determined the appropriate Corrective / Preventive Actions are finalized. In both the cases customer is informed about the complaint investigation along with Root Cause Analysis and Corrective / Preventive Actions. After getting consensus from the customer, the complaint is closed. The effectiveness of Corrective / Preventive Actions is monitored by checking recurrence of the similar complaint.

Quality Control

  • Traceability of Distributed APIs and Intermediates:

    Traceability of the products is very important in case of any eventuality. We retain all product consignment related documents like; Certificate of Analysis, transportation documents, statutory and regulatory documents, all inspection checklists and any other related document as per the regulatory guidelines.

  • Information Management:

    Our Quality Agreements stipulate the requirement of Quality and Regulatory information to be shared with the customer. Some of the information like; Process Description, Specification, Test Methods, Labeling requirements, etc. are shared before start of the business and are updated as and when needed. The batch wise information like; Certificate of Analysis, packing list, etc. is provided along with each consignment.

  • Compliant Management:

    Quality Assurance Department is responsible for management of Customer Complaint. PRISCA aims for ZERO Customer Complaint and puts in all its’ efforts to achieve it. In spite of all our efforts, if we receive any Customer Complaint, we manage it with a defined procedure. When we receive the complaint, we register and review the nature of the complaint. If complaint is Quality or Quantity related then the details are passed on to Manufacturer for the Root Cause Analysis and Corrective / Preventive Action. Logistic and Commercial complaints are investigated at PRISCA. Once the Root Cause is determined the appropriate Corrective / Preventive Actions are finalized. In both the cases customer is informed about the complaint investigation along with Root Cause Analysis and Corrective / Preventive Actions. After getting consensus from the customer, the complaint is closed. The effectiveness of Corrective / Preventive Actions is monitored by checking recurrence of the similar complaint.

  • Returns:

    Handling of Returned Material is a critical cGMP aspect. We maintain the Records of returned product. The record include, Name and address of the customer, Name & address of the manufacturer, name of the product, batch number and quantity, reason for return, and disposal of the returned product. Upon receipt the returned product is clearly identified / labeled and isolated. The manufacturer is informed about the incident and after completing all statutory and regulatory requirements the product is securely transported to the manufacturer. The Returns are investigated as per the Complaint handling procedure.

Quality

PRISCA is associated with state of-the-art FDA approved laboratories in Mumbai. It supports testing and analysis of wide range of products as per National and International standards.

PRISCA has qualified personnel who are well trained to inspect & check the material before the shipment. PRISCA’s personnel visits the site of manufacturer who shall prepare batch wise composite samples in 3 sets wherein 1st sample is sent to customer for pre-shipment sample evaluation, 2nd set of sample sent to testing laboratories to ensure the results are matching with customer’s specification & 3rd set of sample is kept with PRISCA as reserve sample for future purpose.

PRISCA is also provides details analysis for Working Standard, Reference Standard and Impurity Standard samples.


  • Our Analytical Capabilities :

    The laboratories are well equipped with latest high end instruments to undertake the various types of analysis including Method validation by various analytical techniques.

  • Our Testing Hightlightsare :
    Estimating Purity of Pharmaceuticals Organic Volatile impurities (OVI)
    Impurity profile Residual solvents
    Chromatographic purity / Related substances Dissolution Profile
    Organic & Inorganic compounds Content Uniformity
  • Analytical Instrumentation’s :
    High Performance Liquid Chromatograph Automatic Protein Analyser
    High Performance Thin Layer Chromatograph Dissolution Test Apparatus
    Gas Liquid Chromatograph Melt Flow Index
    Inductively Coupled Plasma Nuclear Magnetic Resonance Spectroscopy
    Atomic Absorption Spectrophotometer Gas Chromatograph Mass Spectrometer
    UV-Vis Spectrophotometer X-Ray Diffraction Element Analysis
    Fourier Transform Infrared Spectrophotometer Differential Scanning Calorimetry / Thermogravimetric Analysis
    Raman Spectrum

OUR FOCUS

  • We, at Prisca, are committed in providing affordable pharmaceutical Active ingredients of global quality standards to several companies all over the world. We supplying the material from various Indian good manufacturing facilities, approved by various regulatory bodies like; Japan, Korea Europe & USA.

    Our APIs product portfolio consists of more than 100 molecules catering to needs in various therapies. These includes Anti-Infectives, Cardiovascular, Anti—Diabetic, Antibiotics, Antipsychotic, Anti-inflammatory, Anti-Cancer, Anti-Ulcerative, Anaesthetic, Anti-Asthmatic, Antidiarrhoeal, Antidepressants, Antifungal, Antiparkinson, Antitubercular, Erectile Dysfunction, Ophthalmic, Urologicals, etc.

    We believe in supplying best quality APIs, hence we continuously work closely with our manufacturers to offer products which can meet the International standards of Production, Technology and Quality Control.

Corporate office

Vasanth Nagar colony, Kukatpally,
Hyderabad 500072
TS

Contact us

Call Us: 9676078326 | 7382120680
Email Us: mail@priscapharmaceuticals.com