maintenance of records

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records and documents

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Slide 1:

1 Presented by: Alok Kumar Vishwakarma Bipin katiyar Mahendra singh M.Pharm(pharmaceutics) PSIT kanpur, Maintenance of records

Introduction:

2 Introduction Maintenance records are written notes that provide documentation about the upkeep of a certain piece of equipment. Put simply, a record can be defined as "evidence of an event". This documentation can prove useful to a variety of different businesses – from a large industrial plant to a small lawn mowing company. These records are particularly useful in maintenance management because they help businesses ensure their equipment is kept in good condition. A record can be either a tangible object or digital information: for example, birth certificates , medical x-rays , office documents , databases , application data , and e-mail

Def. according to ISO & ICA:

3 Def. according to ISO & ICA The ISO defines records as "information created, received, and maintained as evidence and information by an organization or person , in pursuance of legal obligations or in the transaction of business". The International Council on Archives (ICA) Committee on Electronic Records defines a record as "a recorded information produced or received in the initiation, conduct or completion of an institutional or individual activity and that comprises content, context and structure sufficient to provide evidence of the activity."

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4 The quality assessment system needs to be documented carefully and all relevant information is preserved in a systematic way and to provide people with precisely the document or information they need. Now a days, “Quality Assurance System” under ISO-9000 emphasises the importance of maintaining all the records and perfect documentation, for the safety worthiness of the food

Records :

5 Records The GMP inspectorate should maintain a system of records to suit its particular method of operation and circumstances. it must comply with the relevant obligations under national legislation and demonstrate that the quality system is operating satisfactorily. Records should be available which demonstrate that all the relevant procedures have been followed in the performance of each GMP inspection, the recommendation for issue of routine inspections and corrective action. All records should be safely stored for an adequate period ,and held under conditions that guarantee their security and confidentially , unless otherwise required by the national legislation. NOTE :- All records are documents, but not all documents are records

Slide 6:

6 The following records are required to be maintained in a quality assessment system- 1)      Priority/ Sample Register 2)      Analysis Report Register 3)      Check Sampling Analysis Register 4)      Moisture testing report Register 5)      Rejection Record Register 6)      Label /Seal Records 7)      Label/ Certification charges or Fee Register 8)      Certification of Agmark Grading Register (CAG), in case of grading under Agmark only. 9)      Record of Inspection of Laboratory and Equipment and Calibration of Instruments 10)  Grading Statistics Register

Slide 7:

7 Similarly ISO-9000 is also based on perfect documentation and maintenance of records in areas where its absence would have an adverse effect on quality, for accrediting the system of production and awarding ISO-9000 certification as a mark of accreditation . The maintaining of records helps in implementing the quality system elements and is one of the important instruments in resolving the disputes originating on quality grounds.

Use Of Maintenance Records :

8 Use Of Maintenance Records The use of maintenance records is particularly important in a factory setting, where a large number of expensive machines are used daily. These records can help make sure that any appropriate equipment maintenance or plant maintenance has been completed so that plant operations will run smoothly. For instance, a maintenance log detailing any repairs or service upkeep may be kept on a factory machine. This log can help avoid accidents or plant shut-downs resulting from defective equipment

Maintenance Record Management :

9 Maintenance Record Management Maintenance record management can be important for a number of reasons:- Good records help department managers and employees ensure that a piece of equipment is performing in line with any manufacturer warranties. Maintenance records also help companies track when a piece of equipment needs to undergo preventive maintenance . If a company gets sued in relation to a faulty piece of equipment, maintenance records can be essential in supporting the company's case.

RECORD KEEPING REQUIREMENS:

10 RECORD KEEPING REQUIREMENS

Record keeping:

11 Record keeping Records provide history of a batch 1. Name and address of supplier of each drug product with date 2. Name and address of purchaser of each drug product with date 3. Supplier or purchaser licensed 4. Retention of order forms, copy of delivery notes, stores receipt, and issue vouchers ,and book of records (controlled drugs book/prescription drugs book) on the premises as provided for in the drug laws. 5. Accuracy of records kept.

Purpose And Principle Of Records :

12 Purpose And Principle Of Records 1.Scientific 2.Regulatory requirement 3.Business purpose Maintenance of Records is the essential part of quality assurance system Records must be free from errors

Types Of Record:

13 Types Of Record Master Formula Records Batch Processing Records Batch Packaging Records Batch Production Records Quality Records Lot Processing Records and Distribution Records Calibration records Inventory records Personnel records Sanitation records Dosier records Distribution records Raw material records

Master Formula Records:

14 Master Formula Records There should be master formula record relating to all manufacturing procedures for each product and batch size to be manufactured. The master formula shall include : 1. The name of the product together product reference code relating to its with specifications. 2. The patent or proprietary name of the product along with the generic name, a description of the dosage form, strength, composition of the product and batch size. 3. Name, quantity and reference no. of all the starting materials to be used. 4. The requirements for storage conditions of the products. 5. Any special precautions to be observed 6. Packing details and specimen labels.

Batch Processing Records :

15 Batch Processing Records A batch processing record should be kept for each batch processed. The method of preparation of such records should be designed to avoid errors. The check which is to be made for the equipments and workstation should be recorded. During processing, the following information should be recorded: (a) The name of the product (b) The no. of the batch being manufactured (c) Dates and times of completion of production (d) The name of the person responsible for each stage of production (e) The batch no. and the quantity of the material used (f) Notes on special problems including details, with signed authorization for any deviation from the master formula

Batch Packaging Records:

16 Batch Packaging Records A batch packaging record should be kept for each batch processed. The method of preparation of such records should be designed to avoid errors. The check which is to be made for the equipments and workstation should be recorded During packaging, the following information should be recorded: (a) The name of the product (b) The no. of the batch being packaged (c) Dates and times of completion of packaging (d) The name of the person responsible for packaging operation (e) Details of the packaging operations carried out or a record of returning product that has not been packaged to the storage area

Batch Production Records:

17 Batch Production Records

Slide 18:

18 In BPR, computer systems are increasingly used to initiate, monitor, adjust manufacturing process and also to record its various parameters.

Quality Records:

19 Quality Records The manufacturer should establish and maintain procedures for identification, collection, indexing, filing, storage, maintenance and availability of quality records. All quality records should be legible and identifiable with the product involved. Quality records should be stored and maintained in such a way that they are readily retrievable.

Lot Processing Records and Distribution Records:

20 Lot Processing Records and Distribution Records Processing records of regular production lots must provide a complete account of the manufacturing history of each lot of a biological preparation. A separate processing record should be prepared for each lot of biological product, and should include the following information: The name and dosage of the product The date of manufacture The lot identification no. The batch no. of each component A specimen of the label An analytical report They shall be retained for at least two years after the expiry date of a lot or batch of a biological product and be available at all times for inspection by the national control authority.

Calibration Records:

21 Calibration Records Calibration records for fixed, portable, and laboratory radiation measuring equipment and individual monitoring devices, shall be maintained and include frequencies, method, dates, personnel, training and traceability of calibration sources to National Institute of Science and Technology or other acceptable standards. Calibration records should be maintained for the following equipment: Portable survey instruments Bioassay measurement equipment Laboratory, counting room and fixed radiation measuring equipment Process and effluent monitors and sampling equipment Radiation area monitors Portal monitors and other personnel contamination monitors Pocket and electronic dosimeters Air sampling equipment Tool and waste monitoring equipment Protective clothing and equipment monitors.

Inventory Record :

22 Inventory Record It often includes history of the recent transactions in each inventory item. Also called stock record . What information should be included in the inventory? An inventory of records held by a section must be comprehensive and cover all records irrespective of their format. An inventory should list the following elements for each record, file or other collection of information: title and locator information provenance, use and owner information relationship with other records retention scheduling and disposal decisions access restrictions physical or software, hardware and media characteristics .

Sanitation :

23 Sanitation Written programmes validated for premises and equipment quality standard for water hygiene, health and clothing practices waste disposal Implementation and training Practices not permitted: eating, smoking unhygienic practices

Personnel Record:

24 Personnel Record Personnel records are those records that employers use, have used, or intend to use to determine an employee’s qualifications for employment, promotion, transfer, additional compensation, disciplinary action, or discharge. However, employers may not gather or keep records of employees’ nonemployment activities, such as an employee’s associations, political activities, or publications unless (1) the activities occur on the employer’s premises or during the employee’s working hours and interfere with the performance of job duties by the employees, (2) the activities constitute criminal conduct, (3) the activities may reasonably be expected to harm the employer’s property, operations, or business, or (4) the activities could cause the employer financial liability. Employers who do decide to maintain personnel records regarding their employees must permit employees to inspect their personnel documents at least twice each calendar year at reasonable intervals. Employers must allow the inspections within seven working days after an employee makes a request unless, under the circumstances (for example, due to the business’s workload), the employer cannot comply with the seven-day deadline. In that case, the employer has an additional seven days in which to allow the inspection.

Retention of records :

25 Retention of records Records should be kept in such a way that activities concerning the production and quality control of active pharmaceutical ingredients are traceable. Records should be retained for at least one year after the expiry of the finished product or for a specified period if there is no expiry date.

Records Maintenance:

26 Records Maintenance The functions of records maintenance include the following essential components: Organizing and filing records Identifying which records to retain, and for how long

The life cycle of a record has three stages: :

27 The life cycle of a record has three stages: Stage 1: Active Use. The record is currently in use and/or is referred to frequently. Stage 2: Semi-Active Use. The record is not in current use but is still referred to on occasion. Records in Stages 1 and 2 are retained and stored for as long as they are useful to the organization, whether that be for six months or ten years. Very few records, if any, are actually in active or semi-active use after ten years. Records no longer in use are in the final stage of the life cycle, Stage 3. Stage 3: Disposition. The record is no longer in current use. It is rarely or never needed for reference. It is no longer needed for legal or financial purposes. Most records in Stage 3 are destroyed or discarded. However, some records have continuing historical value and are retained for the archives

Slide 28:

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