QC AND QA documentation.pptx

The presentation is about documentation in the pharmaceutical industry.
Many important topics are covered i.e. Need, objective, scope, types, and characteristics of documents used in the pharmaceutical industry.
How a document is reviewed, Four tiers of documentation, and the content of main documents like Master formula record, SOPs, Quality audit plan, and reports, and many more topics are covered in this presentation.
Hope you find it helpful.

1. QUALITY CONTROL AND QULAITY ASSURANCE ADITHYA K II SEM M PHARM MPA203T

2. TOPIC DOCUMENTATION IN PHARMACEUTICAL INDUSTRY QUALITY REVIEW QUALITY DOCUMENTATION SPECIFICATION AND TEST PROCEDURES PROTOCOLS AND REPORTS DISTRIBUTION RECORDS

3. CONTENTS DOCUMENTATION INTRODUCTION NEED OF DOCUMENTATION OBJECTIVES OF DOCUMENTATION SCOPE OF DOCUMENTATION TYPES OF DOCUMENTATION CHARACTERISTIC OF DOCUMENT DOCUMENTATION REVIEW DOCUMENTS MODELS FOUR TIERS OF DOCUMENTATION ACC TO ISO 9001 SOPs MASTER FORMUAL RECORD QUALITY AUDIT PLAN AND REPORTS DOCUMENTATION AND COMMUNICATION SPECIFICATION AND TEST PROCEDURES PROTOCOLS AND REPORTS DISTRIBUTION RECORDS

4. DOCUMENTATION INTRODUCTION : What is documentation ? documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use. Documentation provides both ; Information on when, where, who, why and how to complete tasks. Evidence providing that the tasks have been completed as they should be.

5. NEED OF DOCUMENTAITON 1 Mandatory as per regulatory guidelines 2 Keep track of activities 3 Evidence to face legal issues 4 Maintains a historical record

6. OBJECTIVES OF DOCUMENTAITON To define the specifications and procedures for all materials, method of manufacture and control. To ensure that all personnel concern with manufacture know what to do and when to do it. To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale. To ensure the existence of documented evidence, trace ability, and to provide records and an audit trail that will permit investigation. It ensures the availability of the data needed for validation, review and statistical analysis.

7. SCOPE OF DOCUMENTAITON Good documentation encompasses practically all the aspect of pharmaceutical production. Building and premises : installation, validation, cleaning, and maintenance Personnel : training, hygiene etc .

8. SCOPE OF DOCUMENTAITON Equipment : installation, calibration, validation, maintenance, cleaning .

9. SCOPE OF DOCUMENTAITON Materials : specification, testing, ware-housing, disposal. Processing : individual steps in the process of manufacturing. Finished goods : specifications, testing, storage, distribution, and rejection/ disposal.

10. DOCUMENTATION LIFECYCLE DESIGN COMPOSITION REVISION APPROVAL DISTRIBUTION TRAINING UTILIZATION MAINTAIENENCE REVISION ANALYSIS AND DEFINITON OF REQUIREMENTS ABROGATION PREPARATION DIFFUSION USE UPDATING

11. DOCUMENT QUALITY MANUAL POLICIES SOPs BATCH RECORDS TEST METHODS SPECIFICATIONS LOGBOOKS TYPES OF DOCUMENTS

12. TYPES OF DOCUMENT QUALITY MANUAL : A quality manual is a top level document that describes an organizations Quality management system (QMS). It can be used both internally (for employees) and externally (for customers and auditors).

13. TYPES OF DOCUMENT LOG BOOK : all companies are required to keep a logbook for the chronological documentation of equipment- related events such as validation and qualification work, calibration, equipment cleaning preventive maintenance and repairs and unexpected events/ deviations for manufacturing equipment, apparatus, quality control and IPC analytical equipment and utilities.

14. TYPES OF DOCUMENT SOPs : is a set of step by step instructions compile by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations .

15. TYPES OF DOCUMENT BATCH RECORD : the batch record is a product quality controlled document that collects all the data and information to make a regulated product. Batch records record materials, equipment, people, data, labels, and events during the production of products.

16. CHARACTERISTIC OF DOCUMENT For effective use of documents, they should be designed and prepared with utmost care. Each document shall; Have a clear title. Have an identification number. Be approved by authorized person. Have the date of issue. Have a due date of revision. List to whom it has been issued.

17. DOCUMENTATION REVIEW Documentation system should provide for a periodic review and revision if necessary of any document or part there of . Such revised versions shall also be approved by the authorized persons. Updated/revised versions shall also be superseding the previous edition, and the document shall clearly indicate this. Outdate/superseded document shall be immediately removed from active use, and copy retained only for reference.

18. “DOCUMENTS” MODEL D = Design, development, deviations, dossiers and drug master files for regulated markets, distribution records O = Operational procedures/ techniques/ methods, out of specifications (OOS), out of trend (OOT). C = Cleaning, calibration, controls, complaints, containers and closures, contamination and change control. U = user requirement specifications, utilities like water systems, HVAC, AHU etc .

19. “DOCUMENTS” MODEL M = Man, materials, machines, methods, maintenance, manufacturing operations and controls, monitoring, master formula, manuals, medical records. E = Engineering control and practices, Environment control, Equipment qualification documents. N = Non-routine activities, new products and substances. T = technology transfer, training, testing, trend analysis, technical dossiers. S = SOPs, Safety practices , sanitation, storage, self-inspection, standardization, supplier qualification, specifications and standard test procedures and site master file.

20. STANDARD OPERATIONG PROCEDURES (SOP) A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug As s ociati on (PDA ) su r ve y found th a t a typical pharmaceutical company must manage an average of 1250 SOPs. 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. The development and use of SOPs are an integral part of a successful quality system. It provides information to perform a job properly, and consistently in order to achieve pre-determined specification and quality end-result.

21. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION : Tier ISO 9001 Category Content Description Deals with... I Quality manual Corporate Divisional Departmental A time-independent document describing the organization's policies written in conformance with the Standard. Scope of QMS Details of exclusions Documentation of quality policy Documentation of quality objectives Description of organization Identification of processes Description of processes interactions Inclusion or reference of procedures The organization's response to each SHALL The "rules of the house"—the methods used to ensure compliance Definition of responsibility

22. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION : II Process documents and high-level procedures SOPs Departmental operating procedures Business plans Quality plans Time-dependent documents that describe either the overall processes of the organization or a combination of process and high-level procedures Enterprise processes Six mandatory procedures Documents needed to ensure the effective planning, operation, and control of the processes Employee handbook Purpose—what, when, where, who, and why at a high level Flow of information from area to area, department to department, building to building

23. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION : III Lower-level procedural documents Wall reference charts Instructional computer screens Work instructions Directions Time-dependent, detailed step-by-step work instructions on how to complete a task (e.g., at the operator or bench level)—sometimes integrated into tier II documents Purchasing work instructions Manufacturing work instructions Training syllabus How one does the job—tells the reader in a step-by-step fashion Provision of the necessary data to perform the tasks

24. The four suggested operational tiers of ISO 9001 : 2000 DOCUMENTATION : IV Unfilled-in forms, graphics, or spec sheets Templates Blueprints Schematics Specifications Drawings Generally time-independent documents that specify the data requirements called out in the various documents and/or specific data sources, or graphically indicate requirements or state specifications Many of the forms are used as records once they are filled in and filed, although specific records are required at all levels Complementary documents to support work instructions The forms used to demonstrate that a procedure requiring either data taking or data input was done Drawings and/or specifications used in manufacturing or troubleshooting The templates required to measure and fabricate

25. 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 processes continue uninterrupted and are completed on a prescribed schedule. To ensure that no failures occur in manufacturing and other processes that would harm anyone in the surrounding community To ensure that approved procedures are followed in compliance with company and government regulations. To serve as a training document for teaching users about the process for which the SOP was written To serve as a checklist for co-workers who observe job performance to reinforce proper performance. To serve as a checklist for auditors. To serve as an historical record of the how, why and when of steps in an existing process so there is a factual basis for revising those steps when a process or equipment are changed.

26. SOP PROCESS Preparation Review and Approval Frequency of Revisions and Reviews Checklists Document Control Document Tracking and Archival

27. HOW TO WRITE ? OBJECTIVE: To lay down procedure for the preparation of Standard Operating Procedures. SCOPE: This procedure is applicable to all the SOP’s throughout the organization. RESPONSIBILITY: Person Performing: Respective HOD’s of concerning departments Person Monitoring: QA officer/ HOD QA PROCEDURE: All SOP’s shall be computer typed using Times New Roman font.

28. HOW TO WRITE ? Format of SOP shall be as per Annexure SOP/QA/002/1. Each SOP has: Header, Signature block and Body Header : Present on all the pages of SOP and includes Company Logo, Name, address & Concerned Dept.: Company Logo, CHARAK Pharma Limited, Wag Holi-Pune & Name of Concerned Department.

29. HOW TO WRITE ? Document Type: Standard Operating Procedure (In capital bold letters of font size 14) Ref. No.: It is like SOP/DC/YYY-Z Where DC depicts the department code as below: PE: Personnel Department PD: Production Department MT: Maintenance Department QA: Quality Assurance Department QC: Quality Control Department ST: Store Department PU: Purchase Department YYY is the sequential number starting from 001 for each department . And Z is the revision status, starting from for the original version and 1 for the next version and so on. (In capital letters of font size 12).

30. HOW TO WRITE ? Supersedes : It is the Ref. No. of the earlier version. (In capital letters of font size 12). Effective Date : It is the date from which the SOP shall be put in use. The date format has to be DD/MM/YYYY, where DD indicates the date, MM indicates the month & YYYY indicates the year (e.g. 01/11/2007). Date shall be written with blue indelible ink pen. Review Date : It is the Month & Year during which the SOP shall be revised e.g. 21/2013, written with blue indelible ink pen. It shall be maximum 2 years from the effective date. Page No .: It is like X OF Y. Where X is the individual page number and Y is the total number of pages. (In capital letters of font size 12)

31. HOW TO WRITE ? Title : It shall be clear and descriptive. (In bold capital letters of font size 12). Signature Block : It shall be below the header and only on the first page of the SOP. (Titles in the rows & columns shall be in bold letters & other text in normal letters of font size 12. Name and designation shall be typed. And signature and date shall be put in blue indelible ink pen) Prepared by : Signature with date, name and designation of the person from user department who has drafted the SOP. Verified by : Signature with date, name and designation of the HOD or the person from user department who has verified the draft of the SOP. Authorized by : Signature with date, name and designation of the person authorizing SOP, DGM QA or HOD QA.

32. MASTER FORMULA RECORD Master formula record (MFR) is a master document for any pharmaceutical product. It contains all information about the manufacturing process for the product. MFR is prepared by the research and development team of the company and all other documents like BMR and BPR are prepared using MFR by the manufacturing units .

33. PREPARATION OF MASTER FORMULA RECORD A MFR should have following parts : PRODUCT DETAILS : first of all on the first page following details about the product are added. NAME, LOGO and address of the manufacturing company Dosage form name Brand name, Generic name Product code Label claim of all ingredients Product description Batch size Pack size and packing style Shelf life, Storage conditions MFR number and date Supersede MFR number and date Effective batch number Authorization by the production and quality assurance head

34. PREPARATION OF MASTER FORMULA RECORD 2. Flow chart : steps of the manufacturing process to be monitored. Flowchart of the material movement from dispensing to the final product to stores. 3. Equipment : create a list of all required equipment and machines required in the manufacturing process with their capacity. 4. Special instructions : write down the precautions special instructions to follow during the product manufacturing and packing and these should also be added in the batch manufacturing formula. Batch manufacturing formula should include the following. NAME OF INGREDIENTS WITH TEST REFERENCE (AS IP, BP, USP etc) QUANTITY TO BE ADDED OVERAGES TO BE ADDED(%)

35. PREPARATION OF MASTER FORMULA RECORD 5. CALCUTIONS :include the calculation steps of all active materials to get the 100% of the active material. The calculation shall be done using water content or LOD to get 100% potency. 6. MANUFACTURING PROCESS : write all steps in all stages of the manufacturing process. All process steps like shifting, milling, mixing, lubricating, granulation, compression and coating should be written in detail including the process time and yield. Include atmospheric conditions as temperature, humidity and storage conditions for every step. 7. PACKING PROCESS : list of all packing materials with their quantity is written. Line clearance, reconciliation of prined and unprinted packing materials should be included in details. 8. YIELD : include the theoretical, actual yield and acceptance limit of the batch.

36. QUALITY AUDIT PLAN AND REPORTS Conducting internal audits (self inspections) and external audits of suppliers and outsourcing operations are key elements of a good quality system. One aspect of a quality system that is identified in the recently released International Conference on Harmonization (ICH) Q10, “Pharmaceutical Quality System”, and in other quality system standards such as ISO 9001 , is that of conducting audits as a means of evaluating compliance with the objectives of the quality system. Implementation of the quality management system model defined in ICH Q10 should result in achievement of the three main objectives stated in ICH Q10: Achieve product realization , establish and maintain a state of control , and facilitate continual improvement .

37. DOCUMENTATION AND COMMUNICATION The audit results should be documented and communicated to management. The method of documentation and communication including the security and confidentiality of the audit reports should be defined in the procedure. It is important to remember that those responsible for the audited operation should always receive a copy of the report, including outsourcing management and supplier management. Such reports should clearly describe the audit team observations including specific examples when possible. If commitments have been made to implement corrective actions, such commitments should be included in the report. Security of audit reports should be strictly enforced and distribution of the report should be limited. When providing audit reports to external sources such as outsourcing companies or suppliers, a subset of the internal report may be provided as long as the observations are included

38. SPECIFICATION AND TEST PROCEDURES A specification is defined as a list of tests, references to analytical procedures, and appropriate acceptance criteria, which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. "Conformance to specifications" means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities as conditions of approval.

39. PROTOCOLS AND REPORTS A protocol is a written statement to conduct the process along with the procedure, test method, equipment handling, specifications, acceptance criteria, report and approval. The report summarizes all results, gives recommendations for fixing errors and/or improving the overall quality of the speech corpus and gives an executive summary.

40. DISTRIBUTION RECORDS Distribution forms an important activity of the integrated supply chain management of pharmaceutical products. Various persons and entities are often responsible for the handling storage and distribution of such products. The guidelines are intended to apply to all steps in the entire distribution/supply chain Permanent information, written or electronic, should exist for each stored product indicating recommended storage conditions, any precautions to be observed and retest dates. P h armac op o eia requi reme n ts a n d c u rr en t n ati o n a l reg u lat i o n s c o n cer n i ng l abels a n d containers should be respected at all times. P r o c edure s s h o u ld be i n pla c e for t e m p eratu r e mapp i n g, sec u r i ty servi c e s at the warehouse, destruction of unsaleable stocks and on retention of the records.

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