QA And Documentation PDF

QA and Documentation QC check points IG qualified w IE qualified pharmacists...

QA and Documentation QC check points IG qualified w IE qualified pharmacists gain a QA Mm u said this facilities med t.ws qualified if I'm a Effy  Quality Assurance and Good Preparation Practice i  i i m Quality assurance (QA): a wide-ranging concept which covers all factors which individually or collectively influence the quality of a product. It is the arrangements made that aims to ensure that medicines are of the quality required for their intended use. With respect to extemporaneous compounding, QA includes  lab 'Good Preparation Practice (GPP)’. QA ensures that: Ñ Y AMI'T t.ws GMP manifuetuings.ee  Extemporaneous preparations are formulated and prepared in according to current legal requirements and standards  Preparation and quality control (QC) arrangements are documented and in compliance with current GPP requirements  All compounded preparations are of a quality suitable for their intended use. 1 Quality Assurance and Good Preparation Practice  Medicines are only dispensed or released if they have been correctly processed, checked (QC) and stored in accordance with the defined procedures and released by a competent person (e.g., the responsible pharmacist).  Suitable measures are present to ensure that medicines are stored, handled & dispensed/released in such a way that the required quality can be assured throughout their shelf-life or BUD.  Documentation systems are present, organized and updated. mm 4 40 t.mx 5 I  GPP includes the extemporaneous preparation activities and relevant QC arrangements. Gpp IS Hewww.imitii 2 Good Preparation Practice (GPP)  GPP as a part of QA ensures that medicines are consistently prepared to the required quality standards.  GPP requirements:  Personnel should be qualified and trained in accordance with their job description. wo  Responsibilities and competenciesEmesis should be clearly defined.  Facilities and equipment should be suitable for their intended purpose.  Processes related to the preparation of medicines should be performed according to the established guidelines.  Records should show that all the steps required were completed. They should contain the complete history of the medicine. 3  Good Preparation Practice (GPP)  The quality of prepared products should be assessed and documented.  Starting and packaging materials, and medicines, should be handled and stored so that their quality is ensured throughout their shelf life (or BUD). usedate beyond ÑY  Complaints of prepared medicines are evaluated, cause of www quality defects are investigated, and suitable measures are to taken to prevent occurrence of these defects. 4  βpartoG f PP ofQA whichis apart Quality Control (QC) som  Quality control (QC): is a part of GPP concerned with sampling, specifications and testing of compounded preparations.  It ensure that appropriate tests are carried out and that prepared medicines are not released for use until their quality has been found satisfactory. elldefined 5 1 0.6 own to Quality in rocedore  must be built-in to the preparation from the beginning steps to evaluating the final preparation. ƩThing Certain quality control tests can be done while others are j chance  forthefinal outsourced to a contract laboratory. productmeets req 5 Quality Control (QC) everyD8hasitsownQC  β and topical liquids (solutions, suspensions, Quality control of oral emulsions): IE  Weight / volume  pH taken shouldbe  Specific gravity t.sn  Active drug assay Is  Globule size range (emulsions).  Rheological properties/pourability, Minute procedure  Physical observation: welldefinedprescription  Color & clarity, Aries  Physical stability (discoloration, foreign materials, gas formation)  Mold growth 6 Quality Control (QC)  Hard Gelatin Capsules:  Average weight  Individual weight variation,  Dissolution of capsule shell, disintegration and/or dissolution of capsule contents  Active drug assay  Physical appearance:  Color, uniformity, extent of fill, locked,  Physical stability:  Discoloration, changes in appearance. 7 Quality Control (QC)  Ointments, Creams and Gels:  Theoretical weight compared to actual weight  pH  specific gravity  active drug assay  physical observations:  Color, clarity, spatula spread, appearance, feel and rheological properties. 8  cleaningglasswaresinthelabslide12 mm Documentation is d e  Standard Operating Procedures (SOP) EII.IT ai yzfisaqnt SOPs for the handling, compounding, storage, and transport of preparations should be clearly written and should be followed. Material safety Data Sheets (MSDS) material  79,4 2 every sheet hasits Safety data sheets must be available on-site (hard and/or soft copies). MSDS contains information on the potential hazards (health, fire, reactivity and environmental) and how to work safely with the chemical product. 5s aF.ge  Certificates of Analysis ortutoxicity percautionsforpregnaney Certificates of analysis (COAs) should be obtained for every ingredient used in the compounding of drugs. analysisofmaterial 9 MSDS  MSDS of methylcellulose safe 10 MSDS  MSDS of methylcellulose 11 SOPs Examples:  Basic Compounding Documentation: The Master Formula Record  Monitoring Air Temperature and Humidity  Use, Standardization, and Care of a pH Meter  Cleaning of Glassware  Quality Assessment of Oral and Topical Liquids  Quality Assessment of Gels 12 Formulation Master Record (FMR) mainprescription wii  Use a Master Formula Record for any formulation routinely prepared in the pharmacy.  FMR contains the following: 1. Formula name JIM.br ow 2. Name, strength, and dosage form of all ingredients 3. Formula number 4. Quantity prepared 5. Containers used for storage and dispensing 6. Short proof of calculation 7. Equipment required for the compounding 13 Formulation Master Record (FMR)  FMR contains the following (continued): 8. Compounding instructions 9. Product description (e.g., color, texture, odor) 10. Handling instructions 11. Sample labels for the finished formulation 12. Quality control tests that are to be conducted on the preparation. 13. BUD (beyond use date) 14. Risk Assessment 14 Formulation Master Record (FMR) MÉTIS 15  preparations ftp.mikate SULTANATE OF OMAN MOH. ORAL EXTEMPORANEOUS FORMULATIONS, 3rd Edition 2021. 16 Example of USP monograph. offecial notformemorization USP 41 17 chighrisk ÉI t.ie of nature i ii i ii formulation many steps or Effectsoffline SULTANATE OF OMAN MOH. ORAL EXTEMPORANEOUS FORMULATIONS, 3rd Edition 2021. 18 Categories of Nonsterile Compounding According to chapter 795 in USP: The three general categories of nonsterile compounding require different levels of experience, training, and physical facilities: IT Criteria used to determine overall classification include: simpleorcomplex degree of difficulty or complexity of the compounding process stability information and warnings packaging and storage requirements 2022 dosage forms cancelled they complexity of calculations theseCalogeries local versus systemic biological disposition level of risk to the compounder potential for risk of harm to the patient. 19 Categories of Nonsterile Compounding SIMPLE: Making a preparation that: 1. Has USP compounding monograph OR If.É 2. Appears in a peer-reviewed journal article that contains specific quantities of all components, compounding procedure and equipment, and stability data for that formulation with appropriate BUDs ifoneoftheseismissing OR simple i 3. Reconstituting or manipulating commercial products that may require the addition of one or more ingredients as directed by the manufacturer. is Examples include Captopril Oral Solution and Indomethacin Topical Gel 20 Categories of Nonsterile Compounding MODERATE 1. Making a preparation that requires special calculations or procedures supp (such as calibration of dosage unitI mold cavities) to determine quantities of components per preparation or per individualized dosage units. OR mfg mg taklw.mg moderate www.T 2. Making a preparation for which stability data for that specific formulation are not available.whichis anissue Examples include: Morphine Sulfate Suppositories, diphenhydramine hydrochloride troches, Mixing two or more manufactured cream products when the stability of the mixture is not known. 2 rice incompatibilities 21 Categories of Nonsterile Compounding COMPLEX Making a preparation that requires special training, environment, facilities, equipment, and procedures to ensure appropriate therapeutic outcomes. Examples of possible complex preparation types include transdermal dosage forms, modified-release preparations, and some inserts and suppositories for systemic effects. is Tiki ma's 22  Warm s ghrisk Risk Management o ofpyyy.at o www.s 0 Clay or th how I unarmed low of tohealth control subsamashazards Gg andsafety health IT man II handling tocompounder related ifjka.ge eat preparations, and some inserts and suppositories for systemic effects. 23 Thank You 24