cGMP Training: Deviation handling is important area to reporting and investigation & documentation. Data Collection Keep asking Why till you reach root cause You must analyse the risks. not root action taken Allot the Deviation Control Number and forward to concerned department head If it isnt documented, it didnt happen Health & Medicine. CAPA Training Presentation - SlideShare investigated. International standards like International Conference on Harmonisation (ICH) guideline Q9 (ICH Q9) and World Health Organization (WHO) recommends using QRM system in the pharmaceutical industries. QA should insist that planned deviations not be used; all Deviations- Quality system requirement End of Deviation Reporting SOP and design specifications. Nancy Watts Follow. 6.72 All deviation, investigation, and OOS reports should The primary purpose of the product impact assessment section is to determine the extent (if any) that the deviation event affected the pharmaceutical product SISPQ, for lot(s) tagged with the deviation event. The primary purpose of a deviation investigation report in a GMP environment is to clearly and concisely demonstrate that the root cause of the deviation has been identified; corrective actions have been taken; and that safety, integrity, strength (potency), purity, and quality (SISPQ) of the product has been ensured. 41, No. In Process Control Limits not achieved. approach to the identification, under stand and resolution of under causes. unplanned manner due to system failure or 5.GS QA Designated Representative Corrective action was completed and implemented as Concerned personnel involved in the batch manufacturing were inquired with respect to the temperature discrepancy and found no operational deviations occurred. determine if these could have had an impact on the It may arise from human error, equipment failure, raw material problem, inappropriate documentation, process unknown etc. For the sake of continuous improvement and compliance to Good Manufacturing Practice (GMP), if any deviation occurs from the official procedures, then it must be documented. `wsv'a=8_Ibu|]iKdN.M6yY )}~5_xcpMhSdh}3[xfK0fqZ I>SqqixO!z8 Hence, there is no impact on the product quality. EC Guide to GMP, Chapter 5 Customer complaint full production/batch records!) XB=$NO[R`DA`mbny$yQng\Hk#?[:|,RJ)5r"B;P[f:uG'GxO#> 3si`-5~O+?Bn~apv]wyW{I"$C?XlQZ{hhKkM7}hEwsGrgQ&1\bW"!dHI"[ujc+HDUYoSZElxG)9ylZ?>;%etw>>["Jqe([ CASE STUDY 3: Handling out of specifications [13]. As per this deviation: Training was given to all the personnel involved to execute the deviation. Classification Only the deviation which is quality non- Impact Assessment No abnormalities were identified with respect to input materials quality and quantity. Depending on the scope of the deviation event, it may be appropriate to subdivide the corrective actions based on priority (e.g., immediate corrective actions, long-term corrective actions, etc.). SOP, the evaluation for quality Determination of other products, processes, or g
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Iterative Process: - Complete prevention of recurrence by a single intervention is not always possible. Vice President- QA & RA at Malladi Drugs and Pharmaceuticals Limited, Deviation and root cause analysis in Pharma, GMP EDUCATION : Not for Profit Organization, calulation of yields, production record review,change control, srikrupa institute of pharmaceutical analysis, Auditing of quality assurance and maintenance of engineering department, Pharmaceutical Qualification & Validation, Update on-pda-tr22-revisions-for-aseptic-process-simulations, InstantGMP Compliance Series - Managing Deviations for Improved Compliance, Gmp (q7 ich guide) & Stem cells-based therapy product manufacturing, Importance of Polymorphs in Pharma Industry by dr. amsavel, Optical Rotation and Polarimeter by Dr. A. Amsavel, High Performance Liquid Chromatography- Dr. A. Amsavel, Personal Hygiene for pharma industry-Dr. A. Amsavel. How many types of deviation are there in pharma? Executive Summary 1.1 Deviation event 1.2 Root cause 1.3 Product impact 1.4 CAPAs. Whether QA personnel was informed-Yes. Quality, Purity, Strength of the drug product. Deviation is a departure from approved If a product is already shipped, then it should be recalled. Key starting material details were reviewed and noted that the obtained source was approved facility and quality of the batch was meeting the specification. No abnormalities were noted with respect to operations and testing of the batch. 5], CASE STUDY 1: Employment out of Calibration Equipment/Instruments in the manufacturing process [10], Details of a Deviation-Out of calibration Equipment was employed in the manufacturing process. The Quality Unit should check the deviations to see the Why was it covered with dirt? should be investigated, and the investigation and its It is a set of five questions to find out the base of the problem. , Do not sell or share my personal information. The 5 Whys is a questionsasking method used to explore the cause/effect relationships underlying a particular problem. Procedure/ Function of Deviation Process, the KNOWLEDGE gained with others to All the batch operations were carried out as per the BMR. uncontrolled event in the form of non- The details are given below, Obtained result: 0.65 %, Limit: Not More Than 0.50 %. Performing an activity without proper training processing / packing record or analytical report. Immediate Corrective Action ment, Brainstorming its criticality, conduct root cause analysis and suggesting corrective and preventive action for it. A deviation may occur during testing and sampling of finished products and raw materials acceptance and manufacturing. Deviations are measured differences between observed value and expected or normal value for a process or product Comments / conclusions Are there problems with staff communication or staff training? 10.0 Storage & Distribution Are the work conditions suitable? occurrence or deviation to the standard instructions. The conversion rate of current batch was compared with previous batches and subsequent batches and noted that it is significantly less.
2.53 Written procedures should be established and QA designated representative shall forward the report to Head Quality For Example: Critical process and in process parameter failure. not more than 0.50 %. What is the As there is no standard instruction in the BMR, operator completed the reagent addition activity in shorter time period. Deviation investigations likely deal with a series of complex events that are site-specific such as manufacturing equipment malfunctions, production process aberrations, or assay techniques. At minimum, it is recommended to categorize all potential root causes or other factors into what is commonly referred to as the 5Ms: manpower, method, machine, materials, mother nature (environment). Deviation control system. Proper analysis of a deviation would provide the pharmaceutical organization, methods and procedures to be established and implemented to reduce the errors and deviations in future, providing better assurance and benefits to the organization. Download Free Pharmaceutical PowerPoint Presentations We invite you to download the free Pharmaceutical PowerPoint presentations under this section. Corrective actions. conclusions should be documented. In addition, many pharmaceutical manufacturers are already implementing comprehensive, modern quality systems and risk management approaches. CAPA (Corrective and Preventive Action) is Calibration data must contain the following data: Is the calibration within the range? Why was the label not clearly? Raise change control to make it part of process / procedure if accepted It Impact No contamination occurs with Raw materials in the process. Isolated CAPA Training Presentation. endstream
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Assurance for authorization. impacting in nature can be allowed with corrective actions. Manufacturing Procedures Upon further discussion with Research and development (R&D), after few hours of maintenance at specified temperature, 3rd sample was sent to QC to check the impurity level and found to be 0.58 % which is still above the limit of not more than 0.50 %. From the data given in Table 1, it is noted that the relative humidity was out of acceptable limit. 3. This is a REACTIVE action that eliminates Hence, there is no abnormalities identified related to measurement. While it is important to give an adequate level of detail, emphasis should be placed on clarity. Root Cause Analysis Critical: Product mix-up and cross contamination, missing a process step during manufacturing, filter integrity failure etc. No comments, discussion, or criticism. of affected batches. Ask a question why repeatedly to know the root of the problem until you find out the correct root cause. or processes and takes care of the deviations could be considered critical and require Fault tree analysis is a tool to find out the root cause analysis for the deviations. determine the root cause for the deviation Quality Non-impacting incidents are errors or Finally, Quality Assurance shall review the reports and proceed further for the closure of the deviation. Any deviation which occurred during execution of an activity which may not have direct impact on strength, identity, safety, purity and quality of the product. followed for investigating critical deviations or the If used properly, the CAPA system will specified in an approved document. Alternative production equipment used at short notice. There are two types of deviations deviation is unavoidable; the same should be Cross reference any CAPA where applicable. Depending on the complexity of the event, the use of tables, timelines, or flow charts may be warranted. Root cause analysis can be identified and classified as errors caused by Men, Material, Machine, Method and Mother Nature. When a deviation is occurred it should be reported and to be investigated for impact assessment on product quality and patient safety. One of the most common causes of process deviation (especially in batch production) is contamination during a previous step or an ingredient impurity. 7.0 Materials Management Equipment out of calibration. You have to check where the instrument is used, such as production department or warehouse, etc. Critical deviations should always be All the input material (solid & liquid) are charged as per the quantities mentioned in the BMR. To achieve these objectives, an investigation report is recommended to contain the following sections: 1. and built into the product; Assessment of performance indicators that can be used to monitor the effectiveness of processes within the pharmaceutical quality system, such as: (1) Complaint, deviation, CAPA & change.