Standard operating procedures, records and good practice of production

Standard operating procedure:- sops is written procedure for any process or system that is followed during the operation of any system or equipment.

1. STANDARD OPERATING PROCEDURE, RECORDS AND GOOD PRACTICE OF PRODUCTION PRESENTED BY: SRASHTI MAHESHWARI M.PHARM (PHARMACEUTICAL QUALITY ASSURANCE) 1ST YEAR

2. DOCUMENT A DOCUMENT is a piece of written, printed or electronic matter that provides information or serves as an official record.

3. DOCUMENTATION Documentation is the cornerstone of any company’s quality management system and is an essential GMP requirement. Documentation defines a system of information and control so that risks assessment in misinterpretation and error in oral communication are minimized. YOUR DOCUMENTATION IS AN ADVERTISEMENT FOR YOUR WORK.

4. STANDARD OPERATING PROCEDURE Standard Operating Procedure (SOP) is a set of step by step directions or instructions intended to document how to perform a routine activity. It is back bone of pharmaceutical industry. Integral part of quality assurance. SOP provides details of appropriate quality, cost and time limitation.

5. AIMS AND OBJECTIVES OF SOP To achieve quality output. To achieve uniformity of performance. To achieve uniformity of quality. Reduce miscommunication and failure to comply with industry regulation. To provide guidelines for accurate and timely data collection

6. PURPOSE OF SOP Describe how to perform routine activities. Provide training. Guide and standardize working procedures Ensure quality and integrity of data generated\information captured. Reconstructions\repeatability. Provide an auditing tool.

7. TYPES OF SOP Analytical method Preparation of reagent For operating instruments, equipments Safety and precautions Receiving and registration of sample Fundamental SOP To deal with complaints

8. CONTENT OF SOP Company’s name and pagination Title Identification Review and approval Purpose Scope Responsibility Procedure

9. SOP WRITING STYLE SOP’s shall be written in concise, step by step manner. Information should not be complicated. The active voice and present verb tense should be used. Should be short and simple Routine procedures that are short and require few decisions can be written using simple steps format Long procedures involve more than 10 steps and should be written along with graphical format. Procedures that require many decisions should be written along with flowchart.

10. SOP PROCESS SOP preparation SOP review and approval Frequency of revision and reviews Implementing SOP Management of SOP

11. SOP DEVELOPMENT

12. RECORDS Records are used to show that the operations are in compliance with GMP. Records allow companies to trace all the development, manufacturing and testing activities to assess the quality operation in the company.

13. TYPES OF RECORDS Various kind of records maintained in the pharmaceutical industry. Some are as follow: Master formula record Batch manufacturing records Distribution records Batch production records Calibration records Records for stability studies Batch packaging records Quality control records

14. MASTER FORMULA RECORDS (MFR) Master formula record are defined as written procedures that give complete description of all aspects of manufacturing, packaging and control with intention to ensure the purity, identity quality and strength of product. It should be prepared by competent technical staff and should be reviewed by the heads of production and quality control departments.

15. BATCH MANUFACTURING RECORD(BMR) Batch manufacturing record is a written document from the batch that is prepared during the pharmaceutical manufacturing process. It contains actual data of the batch manufacturing and whole manufacturing process step by step. All stages are includes in the batch manufacturing record from the distribution of the raw material to the final packaging. Batch manufacturing record is like a proof that batches were properly made and checked by quality control personnel.

16. DISTRIBUTION RECORD Distribution records are written document which contain data related to distribution of drugs from manufacturer to distributors. They should contain name and strength of the product and description of the dosage form, name and address of the consignee, data and quality shipped and lot or control number of the drug product. These records should be maintained in such a way that a batch related distribution records is easily available. Records for distribution shall be maintained in a manner such that finished batch of a drug can be traced to the retain level to facilitate prompt and complete recall of the batch, if and when necessary.

17. Content of distribution record Product Information Transaction information Distribution information Recipient information

18. BATCH PACKAGING RECORD Batch packaging record should be kept for each batch or part of batch processed. It should be based on the relevant parts of the packaging instruction. It approved by the person responsible for the packaging operations.

19. QUALITY CONTROL RECORDS Quality control records show : Date of performance of test Identification of material Name of supplier Date of receipt Batch number Quantity received Quality of sample taken Statement of result of test Signature of person who performs the test

20. CALIBRATION RECORDS FOR INSTRUMENTS The procedure for calibration records must include the following detail: Name of the instrument Date of calibration Reference standards used Other reagents or tools used Name and sign of the person who calibrated

21. GOOD PRACTICE OF PRODUCTION Production operations must follow clearly defined procedures in accordance with manufacturing and marketing authorisations, with the objective of obtaining products of the requisite quality. All handling of materials and products such as receipt and cleaning, quarantine, sampling, storage, labelling, dispensing, processing, packaging and distribution should be done in accordance with written procedures or instructions and where necessary, recorded.