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[Audio] ESJAY PHARMA PVT.LTD Basic Current Good Manufacturing Practices (cGMP) Presentation Site Address : Plot No: G28,29 SIPCOT Industrial Estate Irungattukottai, Sriperumbudur, Kanchipuram-602117, Tamil Nadu, India..

[Audio] Learning Objectives Updates on regulatory guidelines. The importance of cGMP in our operations. To learn 21 CFR part 210 and 211 guideline requirement. To know data integrity and Good documentation practices..

[Audio] Quality Policy Esjay Pharma business model is developed in compliance with applicable agency (FDA) regulations, codes and standards. Maintain high Quality standards as we design and manufacture our products by the most efficient way to ensure they are affordable to the patients. To benchmark our quality systems against the leading generic pharmaceuticals companies and continually improving the effectiveness of our ‘Quality Management Systems’. All employees have the appropriate Quality, and patient safety and engage everybody’s commitment across our complete value chain and at all levels of our organizations to build the strong Esjay Pharma Quality Culture. education, training, skills and experience to carry out their work competently, in accordance with applicable regulations and Esjay Pharma policies and procedures. Records, documentation and data are managed in accordance with applicable regulations. Each person in Esjay Pharma is accountable for ensuring product..

[Audio] Current Good Manufacturing Practices A set of practices followed in every manufacturing related operation to obtain the product of predefined specifications with as close to zero defect as possible. GMP is always improving and changing hence cGMP. Shared Responsibility of Establishment and Employees. Legal Requirement as per Food Drug & Cosmetic Act Sec. 501(a)(2)(B) Requires conformity with Current Good Manufacturing Practice (cGMP) for manufacturing of drugs..

[Audio] cGMP- WHY IS IT IMPORTANT TO FOLLOW? Patient Education Clipart, HD Png Download , Transparent Png Image | PNG.ToolXoX.com High Quality Drug products Needs of the patient Safe Efficacious Affordable Stable They are important so that: Ensure the proper design, monitoring, and control of the manufacturing processes and facilities. Assure the identity, strength, and quality of the products. Reduce facility losses and waste. Earn and maintain the trust of consumers..

[Audio] cGMP Importance Patient safety. Quality with Compliance. Right at first time. Meeting Regulatory compliance. On time delivery. Profit. Brand, Trend setters. Why cGMP? Do it make Difference? Get the facility design right from the start. Validate processes. Write good procedures and follow them. Identify who does what. Keep good records. Train and develop staff. Practice good hygiene. Maintain facilities and equipment. Build quality into the whole product lifecycle. Perform regular audits. Golden Rules of GMP.

[Audio] History of GMP Unsanitary condition in meat Products. In 1905, Upton Sinclair published a book “The Jungle”. Exposure of unsanitary condition in meat packaging plants. First time sell of contaminated food or meat was illegal. Sulfanilamide is a drug used to treat streptococcal infections. In 1937 company developed a liquid formulation with diethylene glycol and sent out 633 shipments in 1937. 109 deaths reported due to kidney failure and many of the victims were children. Food Drug and Cosmetic Act was passed in 1938..

[Audio] History of GMP (contd….) Thalidomide was used in pregnant women for morning sickness. It caused serious deformities in developing foetuses and 10,000 cases reported with short arms and legs. Drug Amendments of 1962 required drugs to be tested in animals before humans. Life of Thalidomiders – BMS | Bachelor of Management Studies Unofficial Portal Disaster of 1960 – Thalidomide 7 death reported due to Criminal tamperer was opened the bottle and placed some capsules with cyanide. Johnson & Johnson announced a nationwide recall of 31 million bottles and destroyed. Tamper-resistant packaging regulations for OTC drug. Disaster of 1980 – Poisoned acetaminophen capsules.

[Audio] History of GMP The evolution of GMP in pharmaceutical manufacturing may be traced back to the year 1960/61. The entire Europe was shaken by the birth of over 10,000 deformed babies by women who had consumed a tranquillizer drug ‘thalidomide’ during the period of their pregnancy. The problem was further compounded when the progeny of some of the deformed (Thalidomide babies) persons was also born deformed. The obvious reason of this major tragedy was either the absence or negligence of a study of proper effects of the new drug on the next generation. In India, pharma industry started in around 1900 and was mainly focused on formulations. The Drugs and Cosmetics Acts and Rules were brought into effect in 1945. Till the 1970s, the Indian pharma industry was mostly manufacturing formulations with very few bulk drug/active pharma ingredients..

[Audio] Though, by and large, the quality was genuinely maintained, there was no concept of quality assurance. The terms GMP, documentation, SOPs, BMR validation, qualification, internal audit, training, were unheard of. There used to be only quality control. After 1975, there was a major growth in the industry when many Indian pharma companies entered into bulk drug manufacturing, hence, entering the international market. Naturally, they had to follow the stringent quality requirements of World Health Organization (WHO); thus, there was a gradual introduction of GMP through WHO's international quality requirement..

[Audio] cGMP Importance G “X”P …..”X” replace Good “Warehouse” Practice Good “Manufacturing” Practice Good “Laboratory” Practice Good “Documentation” Practice Good “Distribution” Practice Good “Clinical” Practice Good “Pharmacovigilance” Practice.

[Audio] EU Guidelines-Volume 4 : Part I - Basic Requirements for Medicinal Products Chapter 1 - Pharmaceutical Quality System Chapter 2 – Personnel Chapter 3 - Premise and Equipment Chapter 4 – Documentation Chapter 5 – Production Chapter 6 - Quality Control Chapter 7 - Outsourced activities Chapter 8 - Complaints and Product Recall Chapter 9 - Self Inspection.

[Audio] Part II - Basic Requirements for Active Substances used as Starting Materials Annex 1 - Manufacture of Sterile Medicinal Products Annex 2 -Manufacture of Biological active substances and Medicinal Products for Human Use Annex 3 - Manufacture of Radiopharmaceuticals Annex 4 - Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products Annex 5 -Manufacture of Immunological Veterinary Medicinal Products Annex 6 - Manufacture of Medicinal Gases Annex 7 - Manufacture of Herbal Medicinal Products Annex 8 - Sampling of Starting and Packaging Materials.

[Audio] Part II - Basic Requirements for Active Substances used as Starting Materials(contd..) Annex 9 - Manufacture of Liquids, Creams and Ointments Annex 10 - Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation Annex 11 - Computerised Systems Annex 12 - Use of Ionising Radiation in the Manufacture of Medicinal Products Annex 13 -Manufacture of Investigational Medicinal Products Annex 14 - Manufacture of Products derived from Human Blood or Human Plasma Annex 15 - Qualification and validation Annex 16 - Certification by a Qualified Person and Batch Release Annex 17 - Parametric Release Annex 19 -Reference and Retention Samples.

[Audio] Current Good Manufacturing Practice for Finished Pharmaceuticals (21 CFR- Part 211) Subpart A - General Provisions Subpart B - Organization and Personnel Subpart C - Buildings and Facilities Subpart D - Equipment Subpart E - Control of Components and Drug Product Containers and Closures Subpart F - Production and Process Controls Subpart G - Packaging and Labeling Controls Subpart H - Holding and Distribution Subpart I - Laboratory Controls Subpart J - Records and Reports Subpart K - Returned and Salvaged Drug Products.

[Audio] ICH-International Council of Organization Q1A, Q1B, Q1C, Q1D, Q1E - Q1F Stability. Q2 Analytical Validation. Q3A(R2), Q3B(R2), Q3C (R5) - Q3D Impurities. Q4,Q4A - Q4B – Pharmacopoeias. Q5A - Q5E Quality of Biotechnological Products. Q6A- Q6B Specifications. Q7 Good Manufacturing Practice. Q8 Pharmaceutical Development. Q9 Quality Risk Management. Q10 Pharmaceutical Quality System. Q11 Development and Manufacture of Drug Substances. Q12 Lifecycle Management . Q13 Continuous manufacturing of Drug substances and Drug Products . Q14 Analytical Procedure Development ..

[Audio] The 5 Pillars of GMP in the Pharmaceutical Sector PEOPLE Comprehend Roles and Responsibility Procedures Products Processes Premises Cleanliness and Equipment calibration at all times. Clear Specifications at every phase of production. Guidelines for undertaking critical processes Properly documented, simple and consistent.

[Audio] USFDA System Based Inspection Quality system Materials system Production system Equipment and facility system Packaging and labelling system Laboratory control system.

[Audio] Quality Management System DEFINITION QMS is a Crux of Any Quality and Compliance process. QMS is a set of policies, process and procedures required for planning and execution (production/development) in the core area of an organization. It is a rigorous process, which continually increase the economic and quality value of product and services. It is a regulatory requirement that global regulatory inspectors and ISO auditors consider critical. Implementation of PQS throughout the product lifecycle should facilitate innovation and continual improvement and strengthen then link between Pharmaceutical development and manufacturing activities..

[Audio] Control of Components Material Management There should be Written Procedure available to ensure Receipt Identification Quarantine Storage Handling Sampling Testing Approval or Rejection.

[Audio] Warehouse Function Materials (Raw or Packaging) Receipt & Storage: 1. Approved Vendor 2. Approved Spec. 3. Identity, Location & Environmental condition. Sampling: 1.Procedure and location 2. FIFO 3.Environmental condition 4. Under LAF Dispensing: 1. Procedure 2. FIFO 3. Environmental condition 4.Under LAF ESJAY PHARMA Rejection: 1.Procedure 2.Proper storage & location 3.Disposition.

[Audio] Production System Production System includes: Measures and activities to control the manufacture of in-process materials and drug products including Batch compounding. Dosage form production. In-process sampling and testing. Process validation. Establishing, following, and documenting. Performance of approved manufacturing procedures..

[Audio] Production System Production activities start from Issue of raw materials Weighing of raw materials Mixing & bulk preparation (Intermediates) Filling and packaging Finished products Released to the market..

[Audio] Basic Production Principles Starting materials should be tested and approved according its specification. Production equipment should be cleaned, safe, appropriate in size, and appropriate for product type to be manufactured. Operation on different products should not be carried out simultaneously in the same room, unless there is no potential risk of mix-up and contamination. All materials should bear clear labels and batch numbers. Limited access in production area, only authorized personnel Handling of materials and products should be based on written instruction/procedure, and where necessary, recorded. All work instructions/procedures should be written and approved. Batch manufacturing records should be well recorded by qualified and responsible personnel..

[Audio] Buildings and Facilities Location & construction to facilitate Cleaning Maintenance Operations as appropriate to the type and stage of manufacture Design to Minimize potential mix-up or contamination Limit exposure to objectionable microbiological contaminants Spacious For orderly placement of equipment and materials To allow flow of materials and personnel to prevent mix-ups and contamination Pest.

[Audio] Buildings and Facilities Permanently installed Appropriately identified Located to avoid risks of contamination Drains should be of adequate size and prevent back-siphonage Qualified and appropriately monitored Drawings for these utility systems should be available HVAC systems to minimize risks of contamination and cross-contamination Pipework All utilities.

[Audio] Equipment and Facility System Design and construction features Lighting. Ventilation, air filtration, air heating and cooling. Plumbing, Sewage and refuse. Washing and toilet facilities. Sanitation. Maintenance. Water System Disposal of waste.

[Audio] Organization and Personnel Adequate laboratory facilities. Approving or Rejecting all containers, closures, in-process materials, packaging material, labeling, and drug products, procedures or specifications. Review of production records if errors have occurred, that they have been fully investigated. Approving or rejecting drug products held under contract by another company. Personnel qualifications Education, training and experience or any combination to perform the assigned functions. cGMP training shall be conducted on a continuing basis. Each person responsible for supervising the GMP activities..

[Audio] Organization and Personnel Planning Personnel responsibilities Consultants shall have sufficient education, training and experience, or any combination thereof to advise on the subject for which they are retained. Records shall be maintained stating the name, address and qualifications of any consultants and the type of service they provide. Responsible to follow the Personal Hygiene practices Follow the appropriate gowning procedure for the duties they perform. Personnel shall enter areas of the buildings and facilities as per access provided. Report to supervisor for health conditions or open lesion Definition Of Planning In Management Importance of Setting Goals and Objectives Personnel Hygiene.

[Audio] Packaging and labeling Control Materials examination and usage criteria Packaging & Labelling materials shall be representatively sampled and tested. Obsolete & outdated labels shall be destroyed. Any materials do not meet specifications shall be rejected. Use of appropriate electronic equipment to conduct a 100-percent examination for correct Labelling. Labelling issuance Labels shall be reconcile for the quantities, used and returned. Discrepancies issued found during reconciliation shall be recorded & investigated. Returned labels shall be maintained and stored in a manner to prevent mix-ups and contamination..

[Audio] Laboratory Controls General requirements Establishment of scientifically sound specifications, standards, sampling plans and test procedures conform to appropriate standards of identity, strength, quality and purity. Calibration of instruments at suitable intervals. Any deviation shall be recorded and justified. Definition Of Planning In Management Importance of Setting Goals and Objectives Testing and release for distribution For each batch of drug product, there shall be appropriate laboratory determination of satisfactory conformance to final specifications for the drug product prior to release. Drug products failing to meet established standards or any other relevant quality control criteria shall be rejected..

[Audio] Laboratory Controls Stability testing Stability testing shall include sample size, storage conditions, test intervals, reliable meaningful and specific test methods and an adequate number of batches of each drug product. Stability studies results reviewed by authorized person(s) and generate interim conclusion based on trend analysis. The test procedures shall be in writing for appropriate laboratory testing of component, in-process material, drug product, container and closure to determine conformance to the specifications. Special testing requirements.

[Audio] Laboratory Controls Reserve samples Reserve sample shall be retained for each batch in the same immediate container – closure system in which the drug product is marketed. Retain sample shall be sufficient to permit at least 2 full re-examinations and retained at a defined period. Reserve samples shall be examined visually at least once a year for evidence of deterioration. Any evidence of reserve sample deterioration shall be investigated..

[Audio] Laboratory Controls Out of specifications (OOS) results to be investigated acc. to SOP including e.g. Responsibility of QC Checklist of potential defects in laboratory Checklist of potential defects in production Check of sampling and sampling devices Guidance on re-sampling and re-testing Testing of control sample Definition Of Planning In Management Importance of Setting Goals and Objectives General requirement Tell supervisor if something goes wrong Don’t continue with testing if done improperly Check results prior to discarding sample Have second person check Check acceptance values Stability testing will be done Reserve samples will be kept for final products over the period of the expiration date Electronic equipment Sampling and testing of in-process materials and drug products..

[Audio] Benefits of cGMP To bring internal discipline among the employees, To make the work more simpler and systematic. To avoid any confusion and ambiguity in working system. To achieve the desired quality. To avoid wastage and increase the profitability of the company. To avoid accidents. To achieve customer satisfaction and build up company’s image..

[Audio] Documentation and records Records will be maintained Batch Records Testing Investigations Training Maintenance Cleaning Almost Everything If it was not documented, then it did not happen Written in non erasable ink.

[Audio] Data Integrity and Good Documentation Practices ALCOA principles diagram Data Integrity Elements Attributable Source of data & Who Legible Permanent recording Contemporaneous Recording data and time Original Recording data and time Accurate Data with no errors or editing Complete All data including repeat or re-analysis Available Accessible for review/audit for lifetime of record Enduring Record in enduring media Consistent Data and time stamps in the expected sequence.

[Audio] Consequences of cGMP and Data Integrity. CONSEQUENCES cGMP DATA INTEGRITY Costly lawsuits, lost Serious health licensure, risks and damaged reputations_ lead*tg to loss of bushess time, money, and resources. on one batch of products usuary means all products are tamished. Patients Risk Patient MedZines not meeting Quality Standards; Safety & Organzafion Risk Good Batches Quality Cost; GMP data Reputabon; Breach of Trust Personal Risk Loes of Reputathn. Suspension. Waming Letters. Temma50n. Imprisonment. Regulatory Risk Submiffed Data Impact Leffen. FARs & Recalls. Regulatory Actions.

[Audio] Good Documentation Practices GOOD DOCUMENTATION PRACTICES (GDP) Good documentation practice is a systematic way of preparing, reviewing, approving, issuing, recording, storing and archiving any document. IF IT IS NOT WRITTEN, THEN IT DID NOT HAPPEN A document provides information on when, where, who, why and how to complete the task. The document provides evidence proving that the tasks have been completed as they should be. Documentation should always be done in accordance with applicable written procedure following ALCOA + elements whether paper or electronic..

[Audio] Good Documentation Practices. Good Documentation Practices.

[Audio] Error Correction GDP state “any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or identified at the time of the change. Correction of any entry should allow the original entry to be readable and should provide information on the date of the change, and the person making the change. Therefore, if a mistake is made, do not correct it with whiteout or anything else that would hide or obliterate the original entry. Erasures and overwriting are never acceptable. The individual who made the mistake should line out the mistake by putting a single line through the entry, write the corrected information next to the entry, then initial and date the correction. All corrections should be clear and legible. Date of the correction should be the date the correction was made; not the date the error was made. Back-dating or post-dating of information is not allowed. If there is insufficient room to write the correction next to the entry, then the footnote method will be used to document the correction For electronic records, an audit trail may serve the purpose of traceability if the history can be retrieved and viewed as part of the current record. Any changes to the data, forms, records/documents after it has been signed and dated as reviewed, verified, or signed (wet ink or electronic signature), invalidates the signature. The document should be reviewed, and/or verified again and re-signed. Modification(s) to verified records should be limited to authorized individuals; documentation of modification to critical data should include a reason for the change..

[Audio] Common GDP Errors Illegible and unclear documentation. Use of scrap paper or non-official forms in documentation. Failure to maintain original documentation (raw data). Obliterations or write-overs. Lack of corrections or excessive changes or corrections. Use of outdated or uncontrolled forms for documentation. Study procedures not initialed and dated by person performing the task. Incomplete study records or forms. Incomplete explanation of changes to data entries and how the correct data entry was confirmed..

[Audio] Good Documentation Practices 16.35 → 16.55.

[Audio] . Good Documentation Practices. [image] Good Documentation Practices GDocP PT Mitra Sigma Tekindo.

[Audio] Life Cycle of Documents Preparation Review Approval Distribution Retention Withdrawal Revision history.

[Audio] Good Documentation Practices. Good Documentation Practices.

[Audio] Good Documentation Practices Attributable DON’T DO SIGNATURE OF OTHER PERSON OR DON’T RECORD THE GMP DATA ON BEHALF OF OTHER PERSON TEMPERATURE LOG (Frequency : 30 + 5 minutes) Person XYZ recorded entry , Sign/Date on behalf of ABC Both person XYZ and ABC are recording entry exactly at half an hour, which is not possible. Time of recording should be actual, as per defined frequency and accurate..

[Audio] Logo Esjay C:\Users\atul.sakalle\Desktop\New folder\download (10).jpg Legible LEGIBLE DOCUMENTATION How you read this number? 1.27 2.24 3.29 Always record the data that can be easily readable..

[Audio] Contemporaneous DON’T PERFORM ACTIVITY IN BACK DATE Back date signing done, but doer was absent on that day.

[Audio] Quality Management System Original DON’T RECORD GMP DATA ON UNAUTHORIZED PAPER C:\Users\atul.sakalle\Desktop\New folder\original.jpg C:\Users\atul.sakalle\Desktop\New folder\download (9).jpg Recording on unauthorized paper, Blank pages, back of envelops, Excel / Word file in computer are not acceptable.