Documentation of pharmaceutical processes
"If it's not written down, then it didn't happen!" The basic rules in any GMP Good Manufacturing Practice regulation specify that the drug manufacturer must maintain appropriate documentation and records. Documentation helps create an accurate picture of what a manufacturing unit has done in the past and is doing now, and thus provides a basis for planning what it will do in the future. Regulatory inspectors often spend a lot of time reviewing a company's documents and records during their inspections of manufacturing sites. Effective documentation increases the visibility of the quality assurance system. In the light of the above facts, we have tried to meet the various requirements of GMPCoordinate and GMP requirementsPrepare a comprehensive section on "Documents and Records", followed by a detailed review of the most influential and frequently referenced regulations.
Documentation of pharmaceutical processes is any written statement or evidence of any activity in the pharmaceutical field. Documentation includes defining the manufacturer's information and control system, minimizing the risk of misinterpretation and errors inherent in accidental oral or written communication, providing unambiguous procedures for providing verification of performance, enabling calculation review, and allowing batch history tracing of mirror documents to indicate giving a true picture of any pharmaceutical company.
Documents and products are produced in pharmaceuticals, but regulatory bodies are interested in seeing the documents first. Different documents can describe different activities in pharmacy and its real picture. The various documents produced by the pharmaceutical company are discussed below. Given the importance given to documentation in pharmaceuticals, "good documentation practices" are needed. Good documentation is a systematic process for preparing, reviewing, verifying, issuing, storing and reviewing any documents.
Batch records are an important document which is kept together with the stock sample for up to one year from product expiry and final products only after proper BMR review.are supplied, even after the product has been tested by QC, the product will not be published without checking and completing it. BMRand other documents. Every activity must be available in writing because SOPs are GMP requirementsare. Document control is also an important part of GDP to reduce errors and misuse of any document. Original copy should be prepared for all activities like SOPIt starts from the draft version and is finalized after review and review by QA documentsapproved. The final version should be printed as the original and stamped in red ink as "Original". A photocopy of the original must be issued to the concerned department with the stamp "Control Copy". To issue any document with a signature and date, it must have a history. Each document must have an effective date, review date and revision number.
GDP can be defined as: “Good documentation practice is an essential part of quality assurance and to all aspects of GMPRelated" This definition is based on WHOClearly written documents prevent errors in various activities in pharmacy and any activity in specific documents such as SOPWritten and strictly followed. Verbal communication may cause errors, so all important documents such as the master formula record, procedure and record must be error-free and documented. Preparing a list of required documents is difficult and depends entirely on the activity or company environment. The following are the activity factors that are considered in the design of each document.
1. Type of formulation
2. Country requirements
3. ERP system availabilityor SAP
Purpose of documentation
• Defines specifications and procedures for all materials and manufacturing and control methods
• Ensures that all personnel know what to do and when
• Ensure that authorized persons have all the necessary information to supply the product
• Ensure documentary evidence, traceability, record keeping and audit trail for research
• Ensures availability of data for validation, review and statistical analysis.
Classification of documents
Below is the classification of the documents
• For the organization and personnel.
• For buildings and facilities
• For equipment.
• To handle RM & PM
• To control production and process.
• To control packaging and labeling.
• To hold and distribute
• For laboratory control.
• For records and reports.
• For returns and salvaged final products.
Types of documents used in pharmacy
•Specifications: Compliant with MHRA specifications, describe in detail the requirements that products or materials used or obtained during manufacture must comply with. They serve as a basis for quality assessment. We need specifications:
1. Active and inactive ingredients
2. Printing and packaging raw materials
3. Intermediate and semi-finished product
4. Final product
• SOPsA written and authorized operating manual used as a reference by the person responsible for the operation and also used to train new operators in the performance of the procedure.
• Test Method: A written and approved document that describes the exact test method.
• List: Documents contain a catalog of each object, such as an equipment list.
• Certificates of Analysis: These are valid documents that show analytical reports and acceptance/rejection decisions.
• Warm body
• job description
• Batch production records: This is an important document issued for each batch of product to record the assurance, inspection and maintenance of each batch of product. Major content below BMRThere is.
1. Product name, generic name, strength, shelf life, manufacturing date and expiration date.
2. Complete list of ingredients with full description, codes and quantity to be exported.
3. Statement for theoretical yield and reconciliation.
4. Complete MFG instructionsand control, sampling and testing, specifications and precautions to be observed.
5. Statement for processing location and equipment.
6. Method or reference to the method used to prepare critical equipment, including cleaning, assembly, calibration, and sterilization.
7. Date and time of all activities
8. Line clearance method at each stage
9. Control of labeling and samples for coding in primary, secondary and tertiary packaging materials
10. Deviation record
11. The result of the investigation was done. Find more articles in our database
The main file of the site: is a document that provides all the information of a pharmaceutical factory. To prepare SMFThe following materials are needed.
1. General information, including information related to the organization, production activities, name and address, type of products, description of staff, external technical support site, quality management system.
2. Personnel, organizational chart, qualification, experience and responsibility of key training personnel, health requirements and personnel hygiene clothing
3. Premises and equipment: description of production area, nature of construction and finish, brief description of ventilation, special areas, water system, maintenance of premises, major production and laboratory equipment, maintenance of equipment, calibration and cleaning.
4. Documents, preparation, review and distribution of documents,
5. Production, brief description of manufacturing operations, handling of materials, handling of rejected materials and product, brief description of overall process validation policy.
6. Quality control, quality management system
7. Self-inspection, self-inspection schedule.
8. Change control is a document for reviewing, approving and implementing any changes in system, equipment, process and valid materials etc.
9. Protocols: A written plan that states how validation will be conducted and defines acceptance criteria. For example, the protocol for a manufacturing process identifies processing equipment, critical process parameters/operating ranges, product characteristics, sampling, test data to be collected, number of validation runs, and acceptable test results.
Preparation, issues and use of documents
Documents must be clearly and logically identified to prevent misuse. All necessary information is clearly written. Each document includes:
1. Company name
2. Purpose and title of documents
3. Identification number and appeal number.
4. License date
5. Review date
6. Signature prepared, reviewed and approved by.
7. Distribution list
8. Page number
9. The reason for revision must be documented.
10. Abbreviation and reference
Each document is clear and computerized so that it can be read, the documents issued are signed by a relevant person to show a verified matter. Any corrections are made by single-line cutting with signature and date, do not overwrite. The document to be filled has enough space, a ballpoint pen should be used to fill the manuscript.
The process by which a manufacturer ensures that all procedures used and documentation produced are current, accurate, and approved in accordance with GMP .
The purpose of document control is to control the issuance, possession, use and review of original documents, including
Standard operating procedures
Data collection forms
The main formulas
Performance of the quality assurance unit
At first, the document is prepared by the concerned department and the draft is reviewed by the department. Chief and final draft to QA departmentIt is sent that turns the draft into final documents that are reviewed and approved by an authorized person. Control copies are issued to the relevant department and records of issuance are maintained. After confirming the documents like sops quality assuranceIt should be ensured that all relevant users/departments are trained before running the soup and a record of such training should be maintained. A training coordinator, preferably the head of the user department or any designated person, should be responsible for organizing the training. After successfully running the tutorial on each soup, the soups become effective.
Main soups as"MASTER COPY"Red ink, the original copy under supervision and a photocopy of the original copy with a stamp." CONTROL COPY stamped in blue. Sops distribution listShould be maintained for issue records, change in sopsIt needs to start a change request and all versions of the restored version and the new version will be implemented with training.
Implementation of a good documentation practice for pharmaceutical products, GMP complianceand facilitates regulatory institutions. The main purpose of a GDP is to define the information and control system of producers, to minimize the risk of misinterpretation and errors inherent in normal oral or written communication, to provide unambiguous procedures for providing confirmation of performance and to enable calculations to be checked and the possibility to trace batch history as well as Ensure product quality.
For product purchase advice, please fill out the form below.