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standard operating system

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STANDARD OPERATING PROCEDURE (SOP) SCHEDULE M:

STANDARD OPERATING PROCEDURE (SOP) SCHEDULE M GUIDED BY : Dr. G.N Patel PREPARED By : DHIRENDRA patel Roll NO. 08 DEPARTMENT OF PHARMACEUTICS S.K.PATEL COLLEGE OF PHARMACEUTICAL EDUCATION & RESEARCH, KHERVA

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Standard operating procedures (SOP) is a Back Bone of Pharmaceutical Industries

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Organization Stock Management SOP, Documents & Records Process Improvement Personnel Quality Control Occurrence Management Specimen Management Equipment Data Management Assessment Safety & Waste Management

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The 5M’s of Quality M an M aterial M achinery M anuals/Methodology ( SOP) M otivation

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What is Sop ? Need Of Sop SOPs should be Benefits Of Sop Sop – Writing Styles What should be covered under SOP [ SOP - STANDARD OPERATING PROCEDURE ] Topics

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“ A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity which is followed by employees in an organization ” equipment operation, maintenance and cleaning, validation, cleaning of premises and environmental control, sampling and inspection The development and use of SOPs are an integral part of a successful quality system . What is Sop ? Eg

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In the face of a challenging regulatory environment, some leading Pharmaceutical companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood these goals can be achieved by following certain sets of procedures called as “Standard Operating Procedures” (SOP).

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Procedures are essential for any plant’s effectiveness and efficiency, and they are regulatory requirement in the Pharmaceutical Industry. A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parentral Drug Association survey found that a typical pharmaceutical company must manage an average of 1250

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Path of Workflow

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Each Process Has Procedures Sample collection

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Procedures Must Be Documented—in SOPs Sample collection Standard Operating Procedures (SOPs)

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Need Of Sop SOPs detail the regularly recurring work processes that are to be conducted or followed within an organization. To technical and quality system requirements and to support data quality.

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They may describe, for example, fundamental programmatic actions and technical actions such as processes for maintaining, calibrating... Sops are intended to maintain their quality control and quality assurance processes and ensure compliance with governmental regulations. SOP must contain step by step instructions that employ must refer in daily work to complete various tasks more reliably and consistently.

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SOPs should be Written instructions that specify how a test or procedures is to be performed. How a piece of equipment is operated, maintained and calibrated. Describes “ Standard ” approved procedures. Revision … when planned changes are made or annually

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Original – maintained in a central file. Copies – distributed to locations. Written by the person performing the procedure or who knows the procedure well. QA or QC staff approval

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Benefits Of Sop To provide people with all the safety, health, environmental and operational information necessary to perform a job properly. To ensure that production operations are performed consistently to maintain quality control of processes and products. To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community.

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To serve as a training document for teaching users about the process To serve as a checklist for co-workers To serve as an explanation of steps in a process so they can be reviewed in accident investigations.

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Sop – Writing Styles SOPs shall be written in a concise, step by step, easy to read and follow format. The information presented should be not complicated. The active voice and present verb tense should be used. SOP shall be simple and short. Information should be conveyed clearly and explicitly to remove any doubt as to what is required.

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What should be covered under SOP General Document Preparation Preparation and maintenance of work area Washing and sterilization Decontamination Testing area Receipt of samples Recording and labeling Storage and discarding ………cont

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…… What should be covered Laboratory operations Receipt of reagents, standards, etc – storage Preparation of reagents – labeling and storage Reference material – identification, handling, storage and use Results – results, deviations, errors Reports – generation, distribution Archives maintenance Staff Training, staffing pattern ………..cont

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……What should be covered Equipments Indent, purchase, installation and validation Maintenance Daily checks and records Periodic calibration and validation Trouble shooting and action to be taken Annual maintenance In case of accidents – action to be taken

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……What should be covered Deviations Planned deviations Unplanned deviations Variance Errors Record of all the above

Standard Operating Procedures and Records, regarding -:

Standard Operating Procedures and Records, regarding - Receipt of materials There shall be written Standard Operating Procedures and records for the receipt of each delivery of raw, primary and printed packaging material. 2. The records of the receipts shall include; (a) the name of the material on the delivery note and the number of containers (b) the date of receipt (c) the manufacture and/ or supplier name (d) the manufacturer batch or reference number

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(e) the total quantity and number of containers quantity in each container received (f)any other relevant comment or information There shall be written standard operating procedures for the internal labeling, storage of starting materials, packaging materials and other materials. 4. There shall be Standard Operating Procedures for each instrument and equipment.

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Sampling There shall be written Standard Operating Procedures for sampling which include the person(s) authorized to take the samples. 2. The sampling instruction shall include: (a) The method of sampling and the sampling plan (b) The equipment to be used (c) any precautions to be observed to avoid contamination of the material (d) The quantity of samples to be taken (e) instructions for any required sub-division (f) The types of sample containers to be used

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Batch Numbering 1. There shall be Standard Operating Procedures describing the details of the batch (lot) numbering set up with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number. 2. Standard Operating Procedures applied to a processing stage and to the respective packaging stage shall be same or traceable to demonstrate that they belong to one homogenous mix. 3. Batch number allocation shall be immediately recorded in a logbook or by electronic data processing system. The record shall include date of allocation, product identity and size of batch.

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Testing There shall be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed shall be recorded. Records of Analysis 1. The records shall include the following data: (a) name of the material or product and the dosage form (b) batch number and where appropriate manufacturer and/ or supplier (c) reference to the relevant specifications and testing procedures

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(d) test results, including observations and calculations, and reference to any specifications (e) dates of testing (f) initials of the persons who performed the testing, (g) initials of the persons who verified the testing and the detailed calculations, records of actions taken for 2.There shall be written standard operating procedures and the associated (a) equipment assembly and validation (b) analytical apparatus and calibration (c) maintenance, cleaning and sanitation (d) personnel matters including qualification, training, clothing, hygiene (e) environmental monitoring

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(f) pest control (g) complaints (h) recalls made and (i) returns received

References:

References Drug & P’ceutics Science, GMP for p’ceutics by Sidney H.Willing Volume – 109, Page No. -99-104 Sop Guidelines, D.H. Shah The Science & Practice Of Pharmacy by Remington, 20 th edition, Volume -1, Page No. – 980-985 Standard Operating Procedures: A writing Guide For Dairy farm business by Richard Stup. Pharmaceutical Process Validation Second Edition, Revised and Expanded(I. R. Berry, R. A. Nash, eds.), 1993. http://encyclopedia.thefreedictionary.com/Standard+Operating+Procedures

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GOLDEN WORDS OF SWAMI VIVEKANANDA “ Everything can be sacrificed for truth, but truth can't be for anything”

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