cGMP and Regulatory Updates

OBJECTIVE Microbiological Test of Water is provided to determine compliance with the requirements given in individual monograph/specificaitons. PRINCIPLE Microbial testing of water includes the estimation of the number of viable aerobic bacteria present in a given quality of water. MEDIA PREPARATION Phosphate Buffer pH 7.2 Stock Solution Dissolve 34 g of monobasic Potassium phosphate in about 500 mL of water contained in a 1 L volumetric flask. Adjust to pH 7.2 ± 0.1 by the addition of 4 % w/v aqueous solution of Sodium hydroxide (about 175 mL), add water to volume, and mix. Dispense, sterilize and store under refrigeration. For use, dilute the Stock solution with water in the ratio of 1 to 800, and sterilize in an autoclave at 121 OC for about 15 min. Nutrient Agar Medium Beef Extract 10.0 g Peptone 10.0 g Sodium Chloride 5.0 g Agar 12.0 g Water 1000 mL Dissolve with the aid of heat. Adjust to pH 8.0 to 8.4 with 5 M Sodium Hydroxide and boil for 10 min. Filter , adjust to pH 7.2 to 7....

OBJECTIVE Test for Total Microbial Count is provided to determine compliance with the requirements given in individual monograph / specifications. PRINCIPLE Total microbial count is the estimation of the number of viable aerobic micro-organisms present in the pharmaceutical articles of all kinds, from raw materials to the finished forms. BUFFERS AND MEDIA 1. pH 7.2 Phosphate Buffer Stock Solution Dissolve 34 g of Monobasic Potassium Phosphate in about 500 mL of water contained in a 1000 mL volumetric flask. Adjust to pH 7.2 ± 0.1 by the addition of 4 % w/v aqueous solution of Sodium Hydroxide (about 175 mL), add water to volume, and mix. Dispense and sterilize. Store under refrigeration. For use, dilute the Stock Solution with water in the ration of 1 to 800 , and sterilize in an autoclave at 121 OC , 15 lb pressure for about 15 min. 2. Fluid Soyabean Casein Digest Medium Pancreatic Digest of Casein 17.0 g Papacy Digest of Soybean Meal 3.0 g Sodium Chloride 5.0 g Dibasic Potassium Phos...

OBJECTIVE The test for Abnormal / Undue Toxicity / Safety test is provided to determine compliance with the requirements given in individual monograph / specifications. PRINCIPLE This test is intended to detect any unexpected, unacceptable, biological reactivity in a substance. This is an invitro test designed for safety assessment of biologics and biotechnology derived products. ANIMAL QUARTERS 1. Keep the animals individually in a quiet area with an appropriate uniform temperature allowing a variation of ± 2 OC and uniform humidity and free from disturbance. 2. Carry out the test in a quiet room where there is no risk of disturbance which can excite the animals and in which the room temperature is within 3 OC of that of their living quarters or in which the animals have been kept for at least 18 h before the test. 3. Withhold food from the animals overnight and until the test is completed , with hold water only during the test. TEST FOR UNDUE TOXICITY ( As...

OBJECTIVE The test for Staphylococcus aureus is provided to determine compliance with the requirements given in individual monograph/specifications,. PRINCIPLE Identification of Staphylococcus aureus is the detection of a pathogenic bacteria which causes infection in human body. It can be identified by using specific, differential media which support growth of only Staphylococcus aureus. REAGENT AND MEDIA Fluid Soybean - Casein Digest Medium Pancreatic digest of Casein 17.0 g Papai digest of Soybean meal 3.0 g Sodium Chloride 5.0 g Dibasic Potassium Phosphate 2.5 g Dextrose (C6H12O6.H2O) 2.5 g Distilled Water 1000 mL Final pH after sterilization 7.3 ± 0.2 Dissolve the solids in the water, warming slightly to effect solution. Cool to room temperature and add, if necessary, sufficient 0.1 N Sodium Hydroxide to give a final pH after sterilization of between 7.1 and 7.5. Filter, if necessary, to clarify. Distribute into suitable containers and sterilize in an autoclave at 121 OC for about ...

1.0 OBJECTIVE The test for Anti-microbial preservative - Effectiveness is provided to determine compliance with the requirements given in individual monograph / specifications. 2.0 PRINCIPLE Preservative efficacy test is basically a challenge test in which the function of a preservative in pharmaceutical preparation use to be checked by challenging it with different microorganisms (bacteria, fungi and yeast.) Test Organisms Aspergillus niger IMI 147 007 (ATCC 16404, IP 1431.83) Candida albicans NCPE 3179 (ATCC 10231, IP 48.72) Pseudomonas aeruginosa NCIMB 8626 (ATCC 9027, CIP 82.118) Staphylococcus aureus NCTC 10788 (NCIMB 9518, ATCC 6538, CIP 4.13) . Single-strain challenges are used and the designated micro-organisms are supplemented by other strains or species that may represent likely contaminants to the preparation. For example, Escherichia coli [NCIMB 8545 (ATCC 8739, CIP 53.126)] is used for all oral preparations and Zygosaccharomyces Rouxii[NCYC 381 (IP 2021.92)] for oral prepa...

The test for Pyrogens is provided to determine compliance with the requirements given in individual monograph / specifications. PRINCIPLE Pyrogen test is the measurement of the rise in body temperature of rabbits following the intravenous injection of a sterile solution of a substance being examined. It is designed for products that can be tolerated by the test rabbits in a dose not to exceed 10.0 mL per kg. Weight injected intravenously within a period of to more than 10 min. SELECTION OF ANIMALS 1. Use healthy, adult rabbits of either sex, weighing not less than 1.5 kg, fed a complete and balanced diet not containing antibiotics and showing no loss of body weight during the week preceding the test. 2. The rabbits must not have been used in a similar test : a. during the preceding 3 days (as per BP) or 2 days (as per USP and IP) b. during the preceding 3 weeks (as per BP) or 2 weeks (as per USP and IP) unless the material being examined passed the test Rabbits used in a test for Pyrog...

1.0 OBJECTIVE To lay down a procedure for washing and sterilization of glass apparatus. 2.0 SCOPE This SOP covers the procedure for washing and sterilization of glass apparatus is applicable to Quality Control Department Formulation Units 3.0 RESPONSIBILITY Microbiologist. 4.0 ACCOUNTABILITY Department Head. 5.0 PROCEDURE 5.1 Wash the glassware thoroughly using soap solution (Extran 1.0%) followed by potable water rinses to remove all the traces of the residues. Finally rinse with purified water. 5.2 Dry the washed glassware at 105°C in oven. 5.3 Cover the open ends of glass apparatus with a caps / cotton plugs and wrap with aluminum foil. 5.4 Sterilize in the autoclave at 15 psi, 121 OC for 20 min. 5.5 Keep the sterilized material in separate and labeled area to avoid mix up with unsterilized material. 5.6 Record the details. 5.7 For new glassware follow the following procedure 5.7.1 Treat the glasswa...