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What is a Material Requisition Form?A material requisition form lists the items to be picked from inventory and used in the production process or in the provision of a service to a customer, usually for a specific job. The form usually has three purposes, which are to pick items from stock, relieve the inventory records in the amount of the items picked, and charge the targeted job for the cost of the items requisitioned. The form can also be used as the basis for the reordering of any inventory items that are not currently in stock. Contents of a Material Requisition FormThe information most commonly found on a material requisition form includes:
If the materials are to be delivered to a specific location, there may also be space in the header in which to identify the delivery location. Unless a service invoice is to be prepared from this document, it usually does not include item costs or prices. How Material Requisition Copies are UsedThe requesting person retains a copy of the material requisition form, as does the warehouse staff. Another copy accompanies the picked goods to their eventual destination. If items listed on the form are not in stock, another copy may be sent to the purchasing department for ordering purposes. The material requisition form is not used in a computerized production planning environment, where this picking information is instead sent to the warehouse as an electronic message. How Auditors Use the Material Requisition FormAuditors may trace the flow of material requisition forms through a company, to see if inventory items are being appropriately used and recorded as mandated by company materials handling procedures. If not, the auditors may conclude that they cannot rely upon certain aspects of a company's control systems as part of their audit activities, and so will bolster other audit activities. Terms Similar to the Material Requisition FormA material requisition form may also be known as a purchase requisition form, though a purchase requisition can be used for all types of purchases, not just those involved in the production process. J Young Pharm. 2011 Apr-Jun; 3(2): 138–150. ‘If it’s not written down, then it didn’t happen!’ The basic rules in any good manufacturing practice (GMP) regulations specify that the pharmaceutical manufacturer must maintain proper documentation and records. Documentation helps to build up a detailed picture of what a manufacturing
function has done in the past and what it is doing now and, thus, it provides a basis for planning what it is going to do in the future. Regulatory inspectors, during their inspections of manufacturing sites, often spend much time examining a company’s documents and records. Effective documentation enhances the visibility of the quality assurance system. In light of above facts, we have made an attempt to harmonize different GMP requirements and prepare comprehensive GMP requirements related to
‘documentation and records,’ followed by a meticulous review of the most influential and frequently referred regulations. Keywords: Documentation and records, good manufacturing practices, quality assurance It is a truism that it takes a disaster to happen for people, and especially regulators, to wake up and review the accepted
way of doing things. So, too, with the issue of drug safety and drug quality.[1] The 1972 Devonport, UK, incident resulted in at least five deaths when drug products designed to be sterile became contaminated and recipients developed infections. An unwritten change to autoclave operation, communicated orally between operators, resulted in dextrose intravenous solutions that were not
uniformly sterile. The Clothier inquiry, which examined the causes and contributing factors, identified several violations of what we now consider basic good manufacturing practice (GMP). The chain of events that compromised the safety of the drug product included inadequate maintenance, inadequate understanding of autoclave operation, and regular deviations from the written production instructions (often as an attempt to compensate for equipment malfunction). Together, these
factors resulted in a sterilization cycle that did not assure that all vials in the autoclave were sterilized; thus, some doses were safe, while others led to sepsis in patients who received them. This incident helped to define sterility assurance in an operational way. Processes and requirements for equipment validation were created, and legal right of inspection was explicitly given to the agency. Validation was developed as a means of documenting systematic evaluation of the
sterilization cycle — building in a safety factor — and identifying the critical parameters that need to be controlled to assure process performance. The concept that quality must be designed into the process and cannot be achieved only by testing remains a central tenet of current good manufacturing practice (cGMP). In other words, how you make something helps to define its level of quality. Preventing errors is more effective than finding rejects because it is not possible to detect all
rejects.[2] The current requirement for ’documented evidence’ may be driven by this event of Devenport. GMP is that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use. GMP is aimed primarily at
diminishing the risk inherent in any pharmaceutical production. Such risks are essentially of two types: cross-contamination (in particular, with unexpected contaminants) and mix-ups (for example, false labeling).[3] Worldwide, there are different official regulatory statements and guidelines, both national and international, for GMP for pharmaceutical (or ‘drug’ or ‘medicinal’)
products. They may be regulations (as in the US, Japan, or Korea), directives (as in the EU), guides (as in the UK), codes (as in Australia), or a WHO code (as in many Southeast Asia Countries). Among them, the following stand out as the most influential and most frequently referenced: The US Current Good Manufacturing Practices for Finished Pharmaceuticals regulations (the US
cGMPs).[4] The Guide to Good Manufacturing Practice for Medicinal Products of the European Union (the EC GMP Guide).[5] The ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical
Ingredients.[6] The World Health Organization (WHO) good manufacturing practices.[7] The other guidelines and regulations referred by the pharmaceutical manufacturers are as under: Schedule M ‘Good Manufacturing Practices and Requirements of
Premises, Plant and Equipment for Pharmaceutical Products,’ The Drugs and Cosmetics Act and Rules, India.[8] PIC/S Guide to Good Manufacturing Practice for Medicinal Products.[9] Center for Drug Evaluation and Research (CDER): Manufacturing, Processing, or Holding
Active Pharmaceutical Ingredients.[10] DOCUMENTATIONDocumentation is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Documentation provides the route for auditors to assess the overall quality of operations within a company and the final product. The 10 golden rules of GMP[11]Table 1 describes the 10 golden rules of GMP. Rule No. 3 and 5 describe the importance of documentation and records. Table 1The 10 golden rules of GMP
Basics[12]
General requirements[13]
There are various types of procedures that a GMP facility can follow. Given below is a list of the most common types of documents, along with a brief description of each.
Hierarchical document system[12]
More/less levels may be added/subtracted to meet the company’s specific needs. HARMONIZED REQUIREMENTThe harmonized requirements were prepared after taking into consideration the above mentioned guidance documents/regulatory requirements.[4–10] Site master fileThe manufacturer should prepare a succinct document in the form of a ‘Site Master File,’ containing specific and factual GMP about the production and/or control of pharmaceutical manufacturing procedures carried out at the premises. It should contain the descriptions of the following: General information:
Personnel:
Premises:
Equipment:
Sanitation:
Documentation:
Production:
Quality control:
Loan license manufacture and licensee:
Distribution, complaints, and product recall:
Self inspection:
Export of drugs
Documentation system and specificationsDocumentation is an essential part of the quality assurance system and, as such, should be related to all aspects of GMP. Its aim is to define the specifications for all materials and the method of manufacture and control, to ensure that all personnel concerned with manufacture have the information necessary to decide whether or not to release a batch of a drug for sale, and to provide an audit trail that will permit investigation of the history of any suspected defective batch. The specifications should describe in detail the requirements with which the products or materials used or obtained during manufacture have to conform. They serve as a basis for quality evaluation. Manufacturing formulae and processing and packaging instructions should specify all the starting materials used and describe all processing and packaging operations. Procedures should give directions for performing certain operations, e.g., cleaning, clothing, environmental control, sampling, testing, and equipment operation. Records should provide a history of each batch of product, including its distribution, and also of all other relevant circumstances pertinent to the quality of the final product. Written records should be maintained so that data can be used for evaluating, at least annually, the quality standards of each drug product to determine the need for changes in drug product specifications or manufacturing or control procedures. Written procedures should be established and followed for such evaluations and must include provisions for:
All documents related to the manufacture of intermediates, active pharmaceutical ingredients (API), and finished products should be prepared, reviewed, approved, and distributed according to written procedures. Such documents can be paper-based or in electronic form. Documents should be approved, signed, and dated by the appropriate responsible persons. No document should be changed without authorization and approval. Each specification for raw materials, intermediates, final products, and packing materials should be approved and maintained by the quality control department. Periodic revisions of the specifications must be carried out whenever changes are necessary. The issuance, revision, superseding, and withdrawal of all documents should be controlled, with maintenance of revision histories. When a document has been revised, systems should be operated to prevent inadvertent use of superseded documents. Superseded documents should be retained for a specific period of time. Periodic revisions of the specifications may be necessary to comply with new editions of the national pharmacopoeia or other official compendia. Documents should have unambiguous contents: the title, nature, and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The process of reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process. A procedure should be established for retaining all appropriate documents (e.g., development history reports, scale-up reports, technical transfer reports, process validation reports, training records, production records, control records, and distribution records). The retention periods for these documents should be specified. All production, control, and distribution records should be retained for at least 1 year after the expiry date of the batch. For APIs with retest dates, records should be retained for at least 3 years after the batch is completely distributed. Documents should not be handwritten; however, where documents require the entry of data, these entries may be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries. Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded. During the retention period, originals or copies of records should be readily available at the establishment where the activities described in such records occurred. Records that can be promptly retrieved from another location by electronic or other means are acceptable. Data may be recorded by electronic data processing systems or photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked. If documentation is handled by electronic data processing methods, only authorized persons should be able to enter or modify data in the computer, and there should be a record of changes and deletions. Access should be restricted by passwords or other means and the result of entry of critical data should be independently checked. Batch records that are electronically stored should be protected by back-up transfer onto magnetic tape, microfilm, paper, or other means. Specifications should be established and documented for raw materials, intermediates (where necessary), and API/formulations, as well as for labeling and packaging materials. In addition, specifications may be appropriate for certain other materials, such as process aids, gaskets, or other materials used during the production of intermediates or API/formulations that could critically impact on quality. Acceptance criteria should be established and documented for in-process controls. If electronic signatures are used on documents, they should be authenticated and secure. Equipment cleaning and use recordRecords of major equipment use, cleaning, sanitization and/or sterilization, and maintenance should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment and the name and signature of the person who has performed the cleaning and maintenance. The persons performing and double-checking the cleaning and maintenance should date and sign or initial the log, indicating that the work was performed. Entries in the log should be in chronological order. Cross-contamination should be avoided by appropriate technical or organizational measures, for example:
If equipment is dedicated to manufacturing one intermediate or API, then individual equipment records of different activities like cleaning, maintenance, batch log, etc., are not necessary, provided the batch record has complete traceability of this information. In case of formulation manufacturing, the appropriate cleaning procedure should be established to ensure removal of any residue of the previous product. Records of raw materials, intermediates, labeling, and packaging materialsRecords should be maintained, including:
Starting materials in the storage area should be appropriately labeled. Labels should bear at least the following information:
Master (approved) labels should be maintained for comparison with issued labels. Master production instructions/master production and control records (MPCR)/master formula card (MFC)To ensure uniformity from batch to batch, master production instructions for each intermediate or API/finished product should be prepared, dated, and signed by one person and independently checked, dated, and signed by a second person in the quality unit(s). Competent persons experienced in production and quality control should be responsible for the content and distribution within the firm of instructions and master formulae. These should be duly signed and dated. Outdated master formulae should be withdrawn but retained for reference. Copies of the master formula should be prepared in a manner that will eliminate any possibility of transcription error. In certain circumstances, for example, in the first production runs following pilot development, the master formula might need to be amended. Any amendments must be formally authorized and signed by competent person(s). The amended document should be replaced at the earliest opportunity by a newly prepared master formula. Processing should be carried out in accordance with the master formula. Master production instructions should include:
Batch production records/batch production and control records (BPCR)/batch manufacturing record (BMR)Batch production records should be prepared for each intermediate and API/formulation and should include complete information relating to the production and control of each batch. The batch production record should be checked before issuance to assure that it is the correct version and a legible accurate reproduction of the appropriate master production instruction. If the batch production record is produced from a separate part of the master document, that document should include a reference to the current master production instruction being used. Before any processing begins, a check should be performed and recorded to ensure that the equipment and workstation are clear of previous products, documents, or materials not required for the planned process and that the equipment is clean and suitable for use. These records should be numbered with a unique batch or identification number and dated and signed when issued. In continuous production, the product code together with the date and time can serve as the unique identifier until the final number is allocated. The batch number should be immediately recorded in a logbook or by electronic data processing system. The record should include date of allocation, product identity, and size of batch. Documentation of completion of each significant step in the batch production records (batch production and control records) should include:
Production and quality control records should be reviewed as part of the approval process of batch release. Any divergence or failure of a batch to meet its specifications should be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure or discrepancy. A written record of the investigation should be made and should include the conclusion and follow-up action. The following information should be recorded at the time each action is taken (the date must be noted and the person responsible should be clearly identified by signature or electronic password):
Laboratory control recordsLaboratory control records should include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays, as follows:
Complete records should also be maintained for:
Complete records should be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions; record should also be maintained of periodic calibration of laboratory instruments, apparatus, gauges, and recording devices. Batch production record reviewWritten procedures should be established and followed for the review and approval of batch production and laboratory control records, including packaging and labeling, to determine compliance of the intermediate or API with established specifications before a batch is released or distributed. Batch production and laboratory control records of critical process steps should be reviewed and approved by the quality unit(s) before an API batch is released or distributed. Production and laboratory control records of non-critical process steps can be reviewed by qualified production personnel or other units, following procedures approved by the quality unit(s). All deviation, investigation, and OOS reports should be reviewed as part of the batch record review before the batch is released. The quality unit(s) can delegate to the production unit the responsibility and authority for release of intermediates, except for those shipped outside the control of the manufacturing company. Distribution record should be maintained and must include the batch number; quantity produced; name, address, and contact details of customer; quantity supplied; and date of supply. POLICY FOR IMPLEMENTATIONThe following approach pertaining to ‘documentation and records’ may be helpful for pharmaceutical manufacturers to meet the expectations of different regulatory agencies. Write good procedures and follow them[11]Think about what happens in a workplace if written procedures are not available. People rely on more senior employees to tell them how to do things and then do their job from memory. This is fine for a company making garden pots, but not so good when the products being made are pharmaceuticals and can even cause death! In the food, drug, and medical device industry it is critical that good procedures are in place to ensure a controlled and consistent performance; it is an essential part of GMP. Procedures should be clear, concise, and logical. Consider hiring a professional technical writer to do the job. Unlike permanent employees, they know how write well and will perform usability tests to ensure that the documents work. Review of procedure by an independent party can also help to improve process. Outline the task before you begin writing the procedure. Create a brief breakdown of the important steps and key points related to the task; a flowchart is a useful tool. Remember that people do not usually read procedures from start to finish; they tend to scan the document for key words. To make information easier to digest and follow, break the procedure into chunks and use the following:
When writing out any procedure, one should try and visualize the person who will be following that procedure. Use language that that person can understand. Do not include too much or too little information. Increase the readability of the instructions by using simple sentences and by writing in a conversational style. Most companies have a 3-year review cycle for their documents; however, this can be set according to the likelihood of change in the process that the document relates to. Following procedures[11]It is all very well to have great written procedures in place but to ensure a controlled and consistent performance they need to be followed; it is a GMP requirement. Frequently, the steps described in a written procedure may not appear to be the most efficient way of working. Taking shortcuts may save time or make the task easier, but one should never deviate from a written procedure without the approval of a supervisor or the quality department. There are two main reasons for this:
Even though the rationale of a particular step may not be immediately apparent, it may have been put there as a check for another stage of the process. Ideas for improvement should always be encouraged, but do not change procedures without assessing the impact on the entire process. Keep good records[11]Good records enable one to track all activities performed during batch manufacture, from the receipt of raw materials to the final product release; they provide a history of the batch and its distribution. It is an essential part of GMP to keep accurate records, and during an audit it helps convey the message that procedures are being followed. It also demonstrates that the processes are known and are under control. Remember!!!
Documents/SOPs requiredThe following documents and procedures should be prepared to fulfill the above mentioned requirements. The data generated through these procedures should be maintained to show compliance with the above mentioned requirements.
CHECKLIST FOR COMPLIANCE ASSESSMENTThe following checkpoints/checklist may help to assess the compliance of ‘documentation and records’ with GMP requirements CONCLUSIONPharmaceutical manufacture and regulation is clearly an international business. With the increasing emphasis on harmonization efforts and standard setting, as well as mutual recognition agreements, knowledge of foreign regulations is a must both for understanding the future direction of these efforts as well as for international supply of drug products. It is anticipated that the approach described here will be a useful reference work for those personnel preparing and using documents for pharmaceutical manufacture. It can serve as a tool for training staff and may prove to be useful for quality assurance professionals for assessment of compliance during self-inspection. It is again emphasized that documentation is a very important aspect of GMP and will enhance the visibility of the quality assurance function.
FootnotesSource of Support: Nil Conflict of Interest: None declared. REFERENCES4. The Code of Federal Regulations Title 21-Food and Drugs Chapter 1 - Food and Drug Administration Department of health and human services Subpart C - Drugs: General part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals Website. Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm [Last cited on 2010 Apr 1] 6. ICH Q7 Good Manufacturing Practice Guide For Active Pharmaceutical Ingredients. Current step 4 version; November 2000 Web site. Available frpm: http://www.ich.org/LOB/media/MEDIA433.pdf [Last cited on 2010 Jan 1] [Google Scholar] 8. Schedule M Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products; The Drugs And Cosmetics Act And Rules The Drugs And Cosmetics Act, 1940, (As Amended Up To The 30th June, 2005) And The Drugs And Cosmetics Rules, 1945; (As Amended Up To The 30th June, 2005) Available from: http://www.cdsco.nic.in/html/DrugsandCosmeticAct.pdf [Last cited on 2007 Jan 27] 9. PIC/S Pharmaceutical Inspection Convention Pharmaceutical Inspection Co-operation Scheme “Guide to Good Manufacturing Practice for Medicinal Products PE 009-9 Part-I; September 2009. Available from: http://www.picscheme.org/publication.php?id=4. [Last cited on 2010 Apr 1] 10. Guidance for Industry: Manufacturing, Processing or Holding Active Pharmaceutical Ingredient, Draft Guidance; USFDA, Centre for Drug Evaluation and Research CDER March 1998 [Google Scholar] Articles from Journal of Young Pharmacists : JYP are provided here courtesy of Elsevier What is a document that specifies the type and quantity of materials to be drawn from the storeroom and identifies the job that will be charged for the cost of the materials?Materials Requisition Form – Detailed source document that specifies the type and quantity of materials drawn from the storeroom and identifies the job to which the cost of materials are charged.
What is the role of materials requisition forms in a job order costing system?Answer: A materials requisition form. tracks materials taken out of raw materials inventory and placed in production. This form specifies the type, quantity, and cost of materials being requested, as well as the number of the job in which the materials will be used.
Which of the following is the basic document that is used to accumulate?The correct answer is job cost sheet.
Which of the following would be debited to record the requisition of indirect materials?The entry to record the indirect material is to debit manufacturing overhead and credit raw materials inventory.
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