Expression of Interest

Expression of Interest

EXPRESSION OF INTEREST

1. REQUIREMENT OF CONSULTANT FOR DOSSIER PREPARATION
We are a Bangalore based CPSE (Government of India Enterprise) engaged in the manufacturing & marketing of Pharmaceutical formulations to domestic and overseas markets. Our products are registered and exported to various African countries, Latin America, Russia, Malaysia, Thailand, Sri Lanka etc. Our manufacturing sitesare approved by PIC/s Malaysia, Zimbabwe and Uganda etc. We are now focusing on EU GMP certification and further business expansion in other countries and registering more products in the existing countries.

In this regard we are seeking a reputed pharmaceutical product regulatory consultants /experts agencies with relevant experience in preparing dossiers in CTD format as per the country specific guidelines.

SCOPE OF CONSULTANCY FOR DOSSIER PREPARATION

  1. Preparation of dossier for registration/re-registration of new formulations/existing formulations as per the specified guidelines of the respective countries in CTD format for the existing countries/new countries with in the stipulated time committed with party.
  2. Necessary support of relevant documents will be extended from KAPL team.
  3. Preparation/Review and submission of queries relevant to the submitted dossiers till the registration is completed.
  4. To complete the registration process within time lines.
  5. Scrutiny of DMFs provided by the vendors as per the guidelines of EDQM, PIC/s, MHRS or any other relevant guidelines as required from time to time.
  6. Preparation/review of protocols/reports of product development, process validation, cleaning validation, stability as per the standard protocols/country specific guidelines.
  7. Preparation/review and submission of variation/amendment applications.
  8. Responses related to medical queries or product complaints related to ADRs.
  9. Assisting for any other specific requirement related to product registration on case to case other than mentioned above.
  10. A copy of all the documents submitted to the regulatory authority/agency shall be sent to the designated authorized person of KAPL.
  11. To interact with the regulatory authority and organize for GMP audits.
  12. Periodic training shall be imparted to the concerned officers with respect to the recent and evolving trends in regulatory requirements.
  13. The progress should be updated to the concerned authority from time to time through a monthly report and meeting.
  14. Charges shall be quoted as a lumpsum on monthly basis inclusive of all expensed and excluding the statutory taxes.
  15. Applicable TDS will be deducted.
  16. Payment will be made within 10 days after approval of the bill by the designated authority.
  17. Duration will be for the period of 12 months from the agreement.

2. REQUIREMENT OF CONSULTANT FOR GMP

We are a Bangalore based CPSE (Government of India Enterprise) engaged in the manufacturing & marketing of Pharmaceutical formulations. Our manufacturing units are approved by PIC/s Malaysia, Zimbabwe, and Uganda etc.

We are now seeking a reputed pharmaceutical consultants/regulatory experts/agencies with suitable experience in making the site ready for various international GMP audit compliance with main focus to EU-GMP.

The consultant with the team shall identify the GMP gaps, suggest remedial measures & help the company in overcoming these gaps.

SCOPE OF CONSULTANCY:

    1. SCOPE: The scope of the consultancy service is for the following manufacturing blocks to prepare for various international GMP audits with main focus to EU GMP.
      1. Cephalosporin Dry Powder Injectable Block (DPP-III)
      2. Penicillin Dry Powder Injectable Block (DPP-I)
      3. Small Volume Injectable Block (SVP)
      4. General Antibiotic Dry Powder Injectable Block (DPP-II)
      5. Oral Solid Dosage Form(OSD)
      6. Quality Control
      7. Utilities (HVAC, Nitrogen, Compressed Air, Water System, Pure Steam) of respective departments
    2. PRE AUDIT PREPARATION:
      1. Pre-audit and gap-analysis by the consultant team having relevant experience.
      2. The consultant team shall provide suggestionfor the remedial action/CAPA.
      3. The CAPA report shall be submitted to Head-QA within a week of audit.
      4. Hand held approach shall be adopted to plug the gaps in association with the KAPL team.
      5. Advance intimation about the schedule of audit shall be conveyed to the consultant.
    3. Supporting the KAPL team during the GMP audits. Consultant’s presence will be required during the audits.
    4. POST AUDIT
      1. Writing the CAPA with suggested remedial measures.
      2. Supporting the team to provide evidences.
      3. Closing the audit observations for the approval of the facility.
    5. Review/re-write of QMS documents, Qualification/Validation protocols, Review of SMF, Quality Manual and Technical Agreements.
    6. Consultant shall provide SOPs/Procedures/Protocols/GXP Documents as and when required.
    7. Review of QC, Production, Engineering and Warehouse documents including procedures and log books.
    8. Coordinating with KAPL team in conducting the Risk Assessment of equipment, facility, process.
    9. TRAINING:
      1. Conducting training on monthly basis.
      2. The topics shall cover GMP/QMS/Good Engineering practice (GEP)/GLP/Good Distribution Practices (GDP), Validations etc.
    10. ENGINEERING TEAM: Consultancy team should have an Engineer with a Pharma manufacturing experienceinparenteral preparations.
      1. The consultant engineer shall guide the KAPL engineering team of any up-gradation/modification/re-designing of the Facility/Equipment/Utilities (HVAC, Compressed air/Nitrogen/Pure steam etc.)/Water system (Purified/WFI)/Mechanical, Electrical, Plumbing (MEP) and shall provide an estimation of approximate cost for implementation.
      2. To prepare URS/BOQ while procuring any new machinery/instrument.
      3. To suggest a vendor for procurement or modification.
      4. To accompany KAPL team while giving the presentation to the management about the modifications.
      5. To guide KAPL team about the re-qualification of equipment/water system etc.
      6. To guide KAPL engineering team on day to day Maintenance/Operation/Improvement/Suggestion/Problem solving of Water system/HVAC/Production equipment/other utilities in order to meet cGMP/GMP/WHO standards. In this regard consultant engineer has to visit KAPL once in 15 days and also as and when situation arises.
    11. The consultancy period will be one year from the date of agreement.
    12. Consultant shall take up the work for minimum of 7 working days in a month and if required an additional day or two shall be obliged without additional charges.
    13. Tentative schedule of activity shall be presented to Head – QA before commencement of the contract.
    14. Charges shall be quoted as lumpsum on monthly basis inclusive of all expenses and excluding the statutory taxes.
    15. Payment will be made within 10 days after the receipt of the bill.

     

  1. NOTE: Technical and commercial bids shall be separately sent to Head – QAB. U. Kamath
    DGM &HOD – QA & RA
    Contact No. 080-28395186 – 188
    Mail Id.:  u.kamath@kaplindia.com