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The concept of validation has expanded through the years to encompass a wide range of activities from analytical methods used for the quality control of the drug substances and drug products to computerized systems for clinical trials. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 2Why validation? : Why validation? It would not be feasible to use the equipments without knowing whether it will produce the product we wanted or not. The pharmaceutical industry uses expensive materials, sophisticated facilities & equipments and highly qualified personnel. The efficient use of these resources is necessary for the continued success of the industry. The cost of product failures, rejects, reworks, and recalls, complaints are the significant parts of the total production cost. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 3Slide 4: Detailed study and control of the manufacturing process- validation is necessary if failure to be reduced and productivity improved. The pharmaceutical industries are concerned about validation because of the following reasons. Assurance of quality Cost reduction Government regulation 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 4Department responsible : Department responsible Site validation committee (SVC) Develop Site master Validation plan, Prepare/execute/approve validation Studies Manufacturing department Prepares the batches as a routine Production batch Quality assurance Ensure compliance , see that Documentations/procedures are in place ,Approves protocols and reports Quality control Perform testing and reviews protocol and report as needed. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 5Responsible authorities for validation : Responsible authorities for validation The validation working party is convened to define, progress,, coordinate and ultimately, approve the entire effort, including all of the documentation generated. The working party would usually include the following staff members, preferably those with a good insight into the company's operation. Head of quality assurance Head of engineering Validation manager Production manager Specialist validation discipline (s)-all areas 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 6Slide 7: Department /Designation Responsibility Manager-Production Responsible for manufacturing of batches and review of protocol and report. Manager – QC Responsible for analysis of samples collected Executive QC- Responsible for samples collection and submission to QC Manager-Maintenance Providing utilities and engineering support Executive – Production Responsible for preparation of protocol and manufacturing of validation batches Manager –QA Responsible for protocol authorization and preparation of summary report. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 7Types Of Validation : Types Of Validation Analytical validation Analytical validation is the evaluation of product quality attributes through testing, to demonstrate reliability is being maintained throughout the product life cycle and that the precision, accuracy, strength, purity and specification has not been compromised. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 8Equipment validation : Equipment validation Validation of equipments is known as qualification. Equipment validation is divided into installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).An IQ documents specific static attributes of a facility or item to prove that the installation of the unit has been correctly performed and that the installation specifications of the manufacturer have been met. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 9Revalidation : Revalidation It is the repetition of a validation process or a specific part of it. This is carried out when there is any change or replacement in formulation, equipment, plant or site location, batch size and in the case of sequential batches that do not meet product and process specifications. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 10Design Qualification (DQ) : Design Qualification (DQ) The design qualification outline the key features of the system designed to address the user requirement regulatory compliance and selection rationale of a particular supplier. Caution should be taken when putting together a design qualification since it will have a major impact on installation, operation and performance qualifications 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 11The following are the key considerations for design qualifications: - : The following are the key considerations for design qualifications: - 1 . Physical dimensions of the equipment and accessories 2. Suitable operating environment of the instrument 3. Health and safety requirement 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 12Qualification and Process Validation : Qualification and Process Validation 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 13Slide 14: Fig . Schematic diagram of processing steps and respective in-process variables During tablet manufacture 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 14Validation of Solid Dosage Forms : Validation of Solid Dosage Forms The objective is to present an overview and to discuss aspects of validation in terms of Pharmaceutical unit operations, i.e., those individual technical operations that comprise the various steps involved in product design and evaluation. The key elements that form the basis of a prospective process validation program is: 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 15Slide 16: There are several important reasons for validating a product and /or process. First, manufacturers are required by law to confirm to GMP regulations. Second, good business dictates that a manufacture avoid the possibility of rejected or recalled batches.third , validation helps to ensure product uniformity, reproductibility , and quality .All pharmaceutical scientists, whether in development, quality assurance, production. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 16Process overview: Process overview 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 17Dispensing : Dispensing i )Check and ensure dispensing booth is clean and line check is given as per current Standard operating procedure. ii)Check and ensure that balance is not due for calibration. Check for zero error in the balance. iii)Check and ensure that the expire date of XXX is later than that of batch expiry date. Retest date is older than day of dispensing iv)Check and ensure that the all materials are issued as per Batch Processing Report. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 182.Sifting : 2.Sifting i )Check and record the temperature and relative humidity in processing area temperature ii)should be 25 ±20° C & RH 45±5%. iii)Check and ensure visually all the equipment and equipment parts are cleaned. iv)Record remarks if any. Check and record the integrity of the sieves before and after sifting through out the processing activity. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 193. Granulation : 3. Granulation Control Parameters 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 20 Fixed Variable (Monitor) Response (Test) Equipment Mixing speeds Amount of granulation Fluid feed rate granulation Time Load Drug distribution Water/ solvent Appearance (size) Power consumption (amp/torque)Slide 21: i )Add ingredient into vessel then Dissolve. ii)Add the other ingredients into saizoner and mix of 5 minutes using impeller at slow speed. iii)Collect, samples at 3,5 and 7 minutes at 5 different places and subject it to analysis for uniformity in content. iv)Add granulating solution and homogenize at slow speed for about 10 minutes. v)After granulation is over check the Loss of drying the wet granules. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 21Slide 22: T1 - Top right T2- Top left B3- Bottom left B4 - Bottom right M5 – Middle 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 22Drying and sizing : Drying and sizing Fixed Variable (Monitor) Response (Test) Bowl charge Inlet/ exhaust air temperature Particle size distribution Porosity of filter bags Product temperature Densities Bowl sieve Drying time Loss on drying Air volume Humidity of incoming air (dew point) Humidity of exhaust air Assay (for heat sensitive materials) 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 23Slide 24: Check and ensure the integrity of the Fluidized bed drying bag. Initially dry the wet granules with air for 10 minutes, Dry the granules are per batch process report instruction. Check the Loss of drying of granules; it should not be not more than 1% at 70°C for 15 minutes. Check and ensure the dried granules are not stored above 25°C before the milling is started. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 24Slide 25: Check and ensure the integrity of the sieves before and after sieving. Pass the granules through 16 mm mesh sieve, break the oversize granules using mill fitted with 2mm screen. Collect the granules in poly bags, and check for flow properties Check the weight of sifted and dried granules. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 25Milling : Milling Variable Response Screen size Milling speed Feed rate Particle size distribution Loose/ tapped densities 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 26Powder blending : Powder blending Variable Response Blending time Blender speed Intensifier bar Content uniformity Assay Particle size distribution Powder flow 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 27Lubrications : Lubrications Variable Response Blending speed Blending time Method of addition Particle size distribution Loose / tapped densities Flow properties Tabletting characteristics (Friability, hardness) 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 28Slide 29: i )Perform the pre mixing and final mixing as per Batch process report instruction ii)During the final mixing before i.e., before adding the remaining quantity of iii)the lubricant mix for 15 minutes. iv)Collects sample at 5,10,15 minute's intervals form top, middle, bottom and 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 29Slide 30: v)Composite and subject it to analysis for assay. vi)After adding the remaining quantity of lubricant mix for 5 minutes. vii)Collects sample at 3,5,7 minutes interval form top, middle, bottom and viii)Composite and subject it to analysis for assay and content uniformity. ix)Check the weight of the final blend and record. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 30Compression : Compression i )Check and ensure the temperature and relative humidity of the compression room is not more than 25°C and Relative Humidity not more than 50%. ii)Check and ensure the compression machine is cleaned iii)Collect 40 tablets and inspect for Appearance, weight, thickness, friability and hardness every 1 hour. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 31Slide 32: iv)Tablets weight variation shall be XX mg. hardness shall be (IP) kg/cm 2 , thickness. v)Collect 40 tablets by " Bracketign " i.e. by increasing this speed of the compression machine form the target speed and by reducing from the targeted speed. vi)Collect 10 tablets during initial, middle and end of the compression process and subjective it to analysis for content uniformity and perform the assay also. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 32Coating : Coating i )Check and ensure the coating pan and other equipment's are cleaned. ii)Check and ensure that the tablets is deducted, the speed of the coating pan inlet and exhaust air temperature, spray rate, spray type, temperature of the coating solution. iii)After coating is completed, samples are collected for dissolution testing and weight variation. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 33Labelling and packing : Labelling and packing Check and record the temperature air the heating roller and sealing roller Check and record that the over printing instructions on labels and cartons. Check and verify that price overprinted on label and carton is as per current price list. After ensuring the proper labeling of tablets, check, for correctness of cartons packing for the same. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 34Finished product analysis and release : Finished product analysis and release Finished product needs to be analyzed as per in-house specification product released only after predetermined specifications and quality attributes. Needs to be released only after pre-determined specifications 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 35Validation of Oral Solutions And Suspensions : Validation of Oral Solutions And Suspensions Introduction The manufacture and control of oral solutions and oral suspensions has presented some problems to the industry. While bioequivalency concerns are minimal (except for the antiseptic products such as phenytoin suspension), there are other issues, which have led to recalls. These include microbiological, potency and stability problems. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 36Slide 37: Additionally, because the population using these oral dosage forms includes newborns, paediatrics and geriatrics that may not be able to take oral solid dosage forms and may be compromised, defective dosage forms can pose a greater risk because of the population being dosed. Thus, this guide will review some of the significant potential problem areas and provide direction to the investigator when giving inspectional coverage. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 37Equipment : Equipment Equipment should be of sanitary design. This includes sanitary pumps, valves, flow meters and other equipment, which can be easily sanitized. Ball valves, packing in pumps and pockets in flow meters have been identified as sources of contamination. In order to facilitate cleaning and sanitization, manufacturing and filling lines should be identified and detailed in drawings and SOPs . In some cases, long delivery lines between manufacturing areas and filling areas have been a source of contamination. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 38Raw materials : Raw materials The physical characteristics, particularly the particle size of the drug substance, are very important for suspensions. As with topical products in which the drug is suspended, particles are usually very fine to micronized (less than 25 microns). For syrups, elixir or solution dosage forms in which there is nothing suspended, particle size and physical characteristics of raw materials are not that important. Examples of a few of the oral suspensions in which a specific and well defined particle size specification for the drug substance is important include phenytoin suspension, carbamazepine suspension, trimethoprim and sulfamethoxazole suspension, and hydrocortisone suspension. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 39Compounding : Compounding In addition to a determination of the final volume (Q.S.) as previously discussed, there are microbiological concerns. For oral suspensions, there is the additional concern with uniformity, particularly because of the potential for segregation during manufacture and storage of the bulk suspension, during transfer to the filling line and during filling. Review the firm's data that support storage times and transfer operations. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 40Microbiological Quality : Microbiological Quality There are some oral liquids in which microbiological contamination can present significant health hazards. For example, some oral liquids, such as nitration suspension are used in infants and immune-compromised patients, and microbiological contamination with organisms, such as Gram-negative organisms, are objectionable. There are other oral liquid preparations such as antacids in which Pseudomonas sp. contamination is also objectionable. For other oral liquids such as cough preparations, the contamination with Pseudomonas sp. might not present the same health hazardprocess . 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 41Oral Suspensions Uniformity : Oral Suspensions Uniformity Those liquid products in which the drug is suspended (and not in solution) present manufacturer and control problems. Those liquid products in which the drug is suspended (and not in solution) present manufacture and control problems. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 42Product Specifications : Product Specifications Important specifications for the manufacture of all solutions include assay and microbial limits. Additional important specifications for suspensions include particle size of the suspended drug, viscosity, pH, and in some cases dissolution. Viscosity can be important from a processing aspect to minimize segregation. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 43Stability : Stability One area that has presented a number of problems includes the assurance of stability of oral liquid products throughout their expiry period. For example, there have been a number of recalls of the vitamins with fluoride oral liquid products because of vitamin degradation. Drugs in the phenothiazine class, such as perphenazine , chlorpromazine and promethazine have also shown evidence of instability. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 44Packaging : Packaging Problems in the packaging of oral liquids have included potency (fill) of unit dose products, accurate calibration of measuring devices such as droppers that are often provided. The USP does not provide for dose uniformity testing for oral solutions. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 45Validation of Sterile Products : Validation of Sterile Products Sterile products have several unique dosage form properties, such as freedom from microorganism, freedom from pyrogens , freedom from particulates, and extremely high standards of purity and quality; however the ultimate goal in the manufacture of a sterile product is absolute absence of microbial contamination. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 46Slide 47: 1. To build sterility into a product 2. To demonstrate to a certain maximum level of probability that the processing and sterilization methods have established sterility to all units of a product batch 3. To provide greater assurance and support of the end product sterility test. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 47Steam sterilization validation : Steam sterilization validation In steam sterilization validation, we care mainly concerned with autoclaving. Before discussing all this lets discuss some important terms, which are repeatedly used in such discussion. These are D value value &F values. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 48D-Value or decimal point reduction time : D-Value or decimal point reduction time It is used to express the rate of killing of microorganisms during sterilization. The death of microbes during sterilization follows first order kinetics. That is regardless of the type of treatment given i.e. whether heat, chemical or radiation, microbes die according to a logarithmic relationship b\w concentration or population of living cells the time of exposure or radiation dose. So the term ‘D’ refers to the time or dose required to reduce the microbial population by one decimal point or for 90% reduction or one log reduction under a given set of conditions 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 49Importance of D-value : Importance of D-value It is a specific kinetic expression for each microorganism in a specific environment subjected to specific sterilization agent on condition. D- value can be used to calculate Z value. D- value can also be used to calculate biological F value. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 50Factors affecting D value : Factors affecting D value Type of microorganism used as biological indicator Formulation components &characteristics like pH Surface on which microorganism is exposed like glass, steel, plastic, rubber etc. Temperature, gas concentration, or radiation dose during sterilization 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 51Determination of D value : Determination of D value Two methods can be used for determination of D value Survivor cycle method Fraction negative method Fraction negative method is less commonly used. In this method, we use replicate samples of identical spore population treated in an identical manner. Then we determine the number (fraction) of samples still showing microbial growth and fraction negative data is used for determining D- values of microorganism exposed to heat sterilization. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 52Slide 53: Survivor curve method: In this method, we 1 st plot the log no. of surviving organisms .Data obtained by this method are plotted semilogarthmically . We use first order rate equation to describe it i.e. Log N= a+bt N=No. Of surviving organisms at time t A=intercept B=Slope of line D is calculated as the reciprocal of linear slope, D=1/b 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 53Z value : Z value In heat sterilization, D value only refers to the resistance of m-gm at a particulate. Z value refers to the influence of temperature changes on resistance of m -gm to heat.Z value can be defined as the increase in temperature required decreasing the D-value of an organism up to 10 th fold or by 90%(1 log cycle reduction) Mathematically value can be expressed as Z = T2-T1 ------------------------ Log D1-logD2 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 54 F value : F value F value is a unit of lethality used to compare the relative sterilizing capacities of different heat processes.F value is a measure of total process lethality It indicates the equivalent amount of time delivered by a heat process at a particular temperature i.e. a reference temperature & a specific z- value . Mathematically it can be expressed as: - t =time interval in minute at temperature T with a specific Z value T=reference temperature E.g.:-It is 121 0 c for steam sterilization. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 55Slide 56: F value F value is nothing; just the F value when Z is 10 0 C & T is 121 0 C So, the equation becomes This term has a great application in steam sterilization. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 56Slide 57: Steam Sterilization by autoclaving Here we are mainly concerned with autoclaving. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 57Heat Distribution Studies: : Heat Distribution Studies: Heat distribution studies can be carried out In empty autoclave chamber. In loaded autoclave chamber. Teflon tape should be used to secure thermocouples. Two thermocouples are taken as references. One is placed in ice-bath and other in increase temperature oil bath during each cycle. The main concern is to identify the coolest spot and the effect of load size and configuration on cool spot location. Difference in temperature between coolest spot and mean chamber temperature should not be more than ± 2.5°C. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 58Heat Penetration Studies: : Heat Penetration Studies: This is the most critical step of the whole validation process. Determination of Fvalue of cold spot is very important. The cold spot for containers ³100ml is determined using container mapping studies. Thermocouple probes are inserted within a container. The cycle is repeated to establish the coldest point. Minimum and Maximum loading configurations should be studied. Thermocouples are placed both inside and outside the container at the cool spot, in steam exhaust line and in constant temperature bath outside the chamber. F 0 value at cool spot is calculated. After attaining the desired temperature, the cycles are repeated until the user is satisfied with the aspects of validation. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 59References : References Rudolf, J. S., Validation of solid dosage forms, 167-187 Madan , J., Prasad, V. and Mishra , P. R., Pharmaceutical validation, 524-548 Hofmann, K. S., Sterile products validation, 89-155 Akers, M. J., Sterilization validation of sterile products, 25-87 Berry,I . R. and Nash, R. A., Pharmaceutical process validation Bowman, F. W., The sterility testing of pharmaceuticals, J. Pharm. Sci., 1969,58, 1301-1308 Brewer, J. H., In antiseptics, disinfectants, fungicides and sterilization, 1957, 160-161 Han, Y. W., Zhang, H. I. and Krochta , J. M., Death rates of bacterial spores, Can. J. Microbiol , 1976, 22, 295-300 Pflug , I. J., Sterilization: science, not art. Med. Device Diag.Ind ., 1981,8-9 McQuillen , D. F., Design and testing of pharmaceutical sterile rooms, Pharm. Tech., 1981, 44. Prout , G., Validation and routine operation of sterile dry powder filling facility, J. Parenter . Drug Assoc., 1982, 36, 199-204 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 60Slide 61: Bunn, J. L. and Sykes, I. K., A chemical indicator for the rapid measurement of F values, J. Appl. Bacteriol , 1981, 51, 143-174 Simmons, P. L., Sterilizer validation, Pharm. Tech., 1979, 2, 69-70 Reich, R. R., Whitbourne , J. E. and McDaniel, A. W., Effect of storage conditions on the performance of Bacillus stearothermophilus biological indicators, J. Parenter , Drug Assoc., 1979, 33, 228 Simmons, P. L., Validation of dry heat sterilizers, Pharm. Eng., 1981, 38 Lachman , L., Liberman , H. A. and Kanig , J. L., The theory and practice of industrial pharmacy, 832-833. Sterility testing and sterility testing of pharmaceutical preparation and biological substances, W. H. O., 1973 Akers, M. J., Ketron , K. and Thompson, B, F value requirements for the destruction of endotoxin in the validation of dry heat sterilization / depyrogenation cycles, J. Parenter . Drug Assoc. 1982, 36, 23-27 The United States Pharmacopeia XX, Mack Publishing Co., Easton, PA, 1980, 1038 Ernst, R. R., West, K. L. and Doyle, J. E., Problem areas in sterility testing, Drug Assoc. Bull., 1969, 23, 29-39 Moats, W. A., Kinetics of thermal death of bacteria, J. Bacteriol , 1971, 105, 165-171 www.fda.gov/ora/inspect_ref/igs/oral.html , Guide to inspections oral solutions and suspensions. www.pifizerIndia.com , Process validation of solid dosage forms. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 61About Authors : About Authors Dr.Nawazish Alam is working as a professor in S.B.S College of Pharmacy, Patti, Punjab, India. Mr.Vikramjit Singh Sandhu,Ms.Monika Doing M.Pharmcy Pharmaceutics at S.B.S College Of Pharmacy Patti Punjab India. 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 62Slide 63: Thank you for listening me……… 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 63Questions?: Questions? 4/10/2011 vikramjit singh,"Dr.Nawazish alam" 64 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.