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  • in reply to: Bioequivalence Study of Generic Drugs #6804
    aid
    Participant

      We know bioequivalence studies are generally performed on the highest strength of a product.

      When can a Bioequivalence study be performed on a lower strength where the applied product has multiple strengths?

      in reply to: FDA Guideline for Data Integrity #6530
      aid
      Participant

        What are the common DI issues from FDA point of view?

        in reply to: Bioequivalence Study of Generic Drugs #6041
        aid
        Participant

          @FRD
          You should consider at least below physicochemical properties of API:
          – Solubility of API
          – pKa, LogP value of API
          – Absorption site of API

          in reply to: Clinical Pharmacy Specialist #5895
          aid
          Participant

            Some of the essential topics you should covered in your pharmacy study program:
            – pharmacy and the law,
            – pharmacology,
            – physiology and pharmaceuticals,
            – Biopharmaceutics,
            – pharmaceutical management and pharmacotherapy etc.

            • This reply was modified 1 year, 4 months ago by .
            in reply to: Biowaiver #5683
            aid
            Participant

              @Pharma
              I got this helpful- https://www.pharmaspecialists.com/p/available-bcs-classification-of-drugs.html

              • This reply was modified 1 year, 5 months ago by .
              • This reply was modified 1 year, 5 months ago by .
              in reply to: GMP Cheklist #5646
              aid
              Participant

                Basic GMP requirements for new pharma manufacturing facility:
                – Appropriate design and location,
                – Proper resources: personnel, buildings, equipment, materials,
                – Clearly defined and systematically reviewed processes,
                – Trained personnel,
                – Proper storage and distribution procedure,
                – Internal and external health and safety,
                – Appropriate waste disposal system etc.

                Reference: https://www.pharmaspecialists.com/2022/03/gmp-facility-design-gmp-golden-rules.html

                in reply to: Biowaiver #5645
                aid
                Participant

                  A biowaiver is applicable when the drug substance(s) in test and reference products (RLD) are
                  identical.

                  BCS-based biowaivers are applicable to drug products where the drug substance or substances exhibit high solubility and, either high permeability (BCS Class I) or low permeability (BCS Class III).

                  In order for a drug product to qualify for a BCS-based biowaiver, criteria with respect to the composition (excipients) and in vitro dissolution performance of the drug product should be satisfied.

                  Ideally, the composition of the test product should mimic that of the reference product. However, where excipient differences exist, they should be assessed for their potential to affect in vivo absorption. This should include consideration of the drug substance properties as well as excipient effects.

                  When applying the BCS based biowaiver approach, comparative in vitro dissolution tests should be conducted using one batch representative of the proposed commercial manufacturing process for the test product relative to the reference product. The test product should originate from a batch of at least 1/10 of production scale or 100,000 units, whichever is greater, unless otherwise justified.

                  To qualify for a BCS-based biowaiver for BCS Class I drug substances, both the test product and reference product should display either very rapid (≥85% for the mean percent dissolved in ≤ 15 minutes) in vitro dissolution characteristics, or rapid (≥85% for the mean percent dissolved in ≤ 30 minutes) and similar in vitro dissolution characteristics (i.e., based on f2 comparison), under all of the defined conditions as below:
                  – Apparatus: paddle or basket.
                  – Volume of dissolution medium: 900 mL or less (it is recommended to use the volume selected for the quality control (QC) test).
                  – Temperature of the dissolution medium: 37±1°C.
                  – Agitation: for paddle apparatus – 50 revolutions per minute (rpm)and for basket apparatus – 100 rpm.
                  – At least 12 units of reference and test product should be used for each dissolution profile determination.
                  – Three buffers: pH 1.2, pH 4.5, and pH 6.8. Pharmacopoeial buffers should be employed. Additional investigation may be required at the pH of minimum solubility (if different from the buffers above).
                  – Organic solvents are not acceptable, and no surfactants should be added.
                  – Samples should be filtered during collection, unless in situ detection methods are used.
                  – For gelatin capsules or tablets with gelatin coatings where cross-linking has been demonstrated, the use of enzymes may be acceptable, if appropriately justified.

                  Two dissolution profiles are considered similar when the f2 value is ≥50. When both test and reference products demonstrate that ≥85% of the labeled amount of the drug is dissolved in 15 minutes, comparison with an f2 test is unnecessary, and the dissolution profiles are considered similar. When the coefficient of variation is too high, f2 calculation is considered inaccurate and a conclusion on similarity in dissolution cannot be made.

                  Reference: M9 Biopharmaceutics Classification System Based Biowaivers

                  in reply to: EU GMP Audit #5644
                  aid
                  Participant

                    Hi Ashiqur!
                    Here is the top 10 check points for facing EU GMP audit:

                    1. Job Training
                    2. Quality Policy
                    3. Good Housekeeping Program
                    4. Equipment Qualification and Calibration Program
                    5. Cleaning Validation
                    6. Test specification and control
                    7. Inventory and Vendor Control Program
                    8. Process Validation Program
                    9. Reprocessing/ Reworking Procedure
                    10. Complaint Handling and Customer Satisfaction Program

                    The above list is not complete but will be important for audit preparation.

                    in reply to: Lyophilized Product Development #5569
                    aid
                    Participant

                      Shelf temperature and chamber pressure are to be considered as critical process parameters for lyophilization.

                      in reply to: Bioequivalence Study of Generic Drugs #5521
                      aid
                      Participant

                        It’s depend on molecule nature, dosage form, patient availability etc.

                        But there are stringent requirements for a generic drug to be claimed bioequivalent to a reference product. One requirement is that the bioavailability of the generic product should be closely similar to that of the reference product.

                        in reply to: Most Stringent Regulatory Authorities #5473
                        aid
                        Participant

                          Following regulatory authorities also highly stringent:
                          UK MHRA
                          Swissmedic
                          SFDA
                          Danish Medicines Agency
                          Norwegian Medicines Agency

                          in reply to: FDA GMP Inspection #5472
                          aid
                          Participant

                            Thanks Pharma!

                            in reply to: Quality Risk Management – ICH Q9 (R1) #4765
                            aid
                            Participant

                              The revised Guideline addresses what constitutes formality in QRM and it outlines how varying degrees of formality may be applied during QRM activities, including when making risk-based decisions.

                              in reply to: FDA GMP Inspection #4569
                              aid
                              Participant

                                What are the most critical check points for pharmaceutical manufacturing facilities to face FDA GMP audit?

                              Viewing 14 posts - 1 through 14 (of 14 total)