DOCUMENTATION RELATING TO PRODUCT DEVELOPMENT,SOP'S,CLEANING METHODS

Views:
 
Category: Education
     
 

Presentation Description

DOCUMENTATION RELATING TO PRODUCT DEVELOPMENT, STANDARD OPERATING PROCEDURES, CLEANING METHODS, QUALITY CONTROL DOCUMENTATION ....Prepared by s.susena. ssj college of pharmacy,hyderabad

Comments

By: mouli248364 (52 month(s) ago)

nice power point

Presentation Transcript

DOCUMENTATION RELATING TO PRODUCT DEVELOPMENT, STANDARD OPERATING PROCEDURES, CLEANING METHODS, QUALITY CONTROL DOCUMENTATION :

DOCUMENTATION RELATING TO PRODUCT DEVELOPMENT, STANDARD OPERATING PROCEDURES, CLEANING METHODS, QUALITY CONTROL DOCUMENTATION PREPARED BY S.SUSENA, SSJ COLLEGE OF PHARMACY, M.PHARMACY(P.ANALYSIS&QA)

PowerPoint Presentation:

DEFINITION Documentation is a process that involves the systematic interaction of people, events and documents to create the records of the organization / corporation. There is saying in the pharmaceutical industry- ‘if it hasn’t been documented, then it hasn’t happened!’ It acts as a proactive vehicle for communication. Document :- A piece of written, typed, printed/electronic matter that provides information/evidence. PRINCIPLES Good documentation constitutes an essential part of the quality assurance system. Clearly written documentation prevents errors from spoken communication and permits tracing of batch history. “Your documentation is an advertisement for your work”. OBJECTIVES To define all materials specifications. To ensure all personal of manufacture and control department know what to do and when to do. To provide information during investigation, if a batch is suspected to have defect(s).

PowerPoint Presentation:

ESSENTIAL CHARACTERISTICS The document directing the manufacturing event fulfills current regulatory commitments. The directive document is appropriate for the task to be performed. The data is accurate and legible. The data is authentic. The data collected fulfills specifications. The original data and the original documents (manufacturing record) are retrievable for review or audit. REQUIREMENTS FOR A GOOD DOCUMENTATION 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.

LIFE CYCLE OF DOCUMENT :

LIFE CYCLE OF DOCUMENT INCEPTION DESIGN PREPARATION APPROVAL CREATION OF NEW DOC. AUTHORIZATION COMMUNICATION TRAINING IMPLEMENTATION PERIODIC REVIEW REVISION REVISED OBSOLESCENCE DOCUMENT WITHDRAWAL ARCHIVING

PowerPoint Presentation:

TYPES OF DOCUMENTS : There are three types of Documents - 1. Commitment Documents : Relationship between industry and the regulatory authorities. Ex: New Drug Applications (NDAs), Drug Master Files (DMFs) etc. These present corporate goals, expectations and standard of practice. Describes what to do . . . . . . ??? It organizes the work in a manner that assures efficient and effective work flow. Written to lead and guide the work and workers. To be used as active documents that are consulted and followed routinely. Deviations from regulatory submissions can have significant impact on product quality. Any deviation must be documented and managed.

PowerPoint Presentation:

New Drug Applications (NDAs):- The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. The goals of the NDA are to provide enough information to permit FDA reviewers to establish the following: Is the drug safe and effective in its proposed use(s) Is the drug’s proposed labeling (package insert) appropriate Are the methods used in manufacturing (Good Manufacturing Practice, GMP) the drug and the controls used to maintain the drug’s quality adequate to preserve the drug’s identity, strength, quality, and purity? Drug Master Files (DMFs):- Drug Master File or DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its discretion to the appropriate regulatory authority in the intended drug market. However, the document provides the regulatory authority with confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. Drug Master File (DMF) is a document containing complete information on an Active Pharmaceutical Ingredient (API) or finished drug dosage form. The DMF contains factual and complete information on a drug product’s chemistry, manufacture, stability, purity, impurity profile, packaging, and the cGMP status of any human drug product.

PowerPoint Presentation:

Directive Documents: Relationship between the Management and Employees. Ex: Specifications, Standard Test Processes (STPs), Standard Operating Procedures (SOPs), Medicinal Product Records (MPRs) etc. They establish the standards for resources, processing, products & quality system. It facilitates the development, production, testing and distribution of a product in a defined manner. Describe how to do . . . . . . ??? There are several types of directive documents which are determined by the specific, functional purpose of the document in the document system. Specifications:- A document specification contains several parts: a description of the audience(s) for the document, a detailed outline giving the structure and contents of the document, and a work plan showing who is responsible for each part of the document and what the deadlines are for completing each task.

PowerPoint Presentation:

There are three purposes for document specifications: Economy of Effort : First, document specifications are used to help you reduce the amount you have to write. E.g.- When you want to write a major report, first you prepare a draft for it, then revise this draft & then make a document out of it. You can often reduce this work load if you write a detailed document specification instead. A document specification is much easier to create, change, revise, and add to than a draft is. Work planning : The second major function of a document specification is work planning. This can mean either budgeting your own time, or distributing the work among many people. You should bear three things in mind in dividing the work: even work load, respective areas of expertise, and getting things done in order that you need them. Writing Organization : The third major function is organization of the report itself.

PowerPoint Presentation:

Standard Operating Procedures (SOPs):- A Standard Operating Procedure (SOP) is a set of written instructions that guide employees in their areas of responsibility. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. 3. Record Documents : Relationship between the Employees and the Work they perform. Ex: Protocols, Batch Production Records (BPRs), Log Books, Calibration Records etc. Protocol:- Protocols are written records clearly defining the objectives and methods that will be used for the validation programs. An important part of the protocol is the description of the testing method including who will test the system, how they will test it and what data is to be collected and reported. Computerized system protocols often include three distinct stages: Installation Qualification(IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

PowerPoint Presentation:

STANDARD OPERATING PROCEDURES (SOP) INTRODUCTION SOPs document a process in the form of ‘who’ ‘what’ ‘when’ and ’how’. They define how a task is to be performed, to achieve a specified outcome and standardize the way it is to be performed so as to minimize variation. BENEFITS SOPs are used as checklists by inspectors when auditing procedure. Ultimately the benefits of valid SOP are reduce work effort, along with improved data comparability and legal defensibility. A collection of well written SOPs and supporting documents can therefore act as critical foundation for process improvement and organization efficiency. TYPES Administrative Type :- It covers permissions and access control to specific data or areas of a facility. Administrative SOPs can be written for wide variety of activities, for example reviewing documentation such as contracts, QA project plans and quality management plans; inspecting (auditing); determining organizational training needs.

PowerPoint Presentation:

Technical Type :- The second type is the technical type, such as operation of the tablet compression machine, i.e. operations being performed by technicians in the production area. Sometimes companies also use more specific types of functional document called work instruction to provide details on how one person accomplishes his or her job. A work instruction in any case is always related to technical procedures rather than administrative ones. CONTENTS OF SOPS An SOP includes:- A list of materials and components required for processing. Full description of reagents, components or handling that must be performed before process initiation. A list of equipment required and its relevant features that may include capacities, precision, and compatibilities and limitations. A stepwise description of the processing event. Process control parameters with testing limits or acceptance criteria.

PowerPoint Presentation:

LIFE CYCLE OF SOPs CREATE/EDIT REVIEW APPROVE PUBLISH DISTRIBUTE ARCHIVE

PowerPoint Presentation:

GUIDE FORMAT FOR SOP This SOP is for oral liquid filling machine. _______________________________________________________ Name of Company _______________________________________ Address ________________________________________________ SOP FOR CLEANING OF LIQUID ORAL FILLING MACHINE SOP NO. …………………. Effective from ……………….. (Date) ________________________________________________________________________ Prepared by checked by Responsibility Section Supervisor ________________________________________________________________________ Approved by In-charge In-charge Production Quality control ________________________________________________________________________ 1. Drain out holding tank of left overs , if any. 2. Fill the holding tank with water up to a height of ________ cm washing the internal surfaces and switch on filling machine. Run the machine till the water is removed from holding tank (as much as is possible). 3. Now open the drain valve of holding tank. 4. Disassemble nozzles and washer. 5. Remove tubing. 6. Clean all parts with jet of water for _______ minutes. 7. Soak parts and flexible tubings in antiseptic solution for 30 min. (0.5% cetrimide solution can be used for this purpose). 8. Wash these parts & tubings in running water. 9. Soak these in previously boiled & hot purified water. 10. If steam is available subject the parts to live steam. If steam is not available, use 70% Isopropyl alcohol and allow to dry. 11. Clean the flexible tubing in the similar way. 12. Cover ends of clean tubing with polyethylene sheets. 13. Clean the holding tank with previously boiled & hot purified water. If steam is not available, treat the holding tank with sodium hypochlorite solution (0.1%). 14. Assemble the equipment. 15. Label the equipment with status label e.g. “Ready for use”. __________________________________________________________________________

PowerPoint Presentation:

SOP DOCUMENTATION Each organization should develop a numbering system to systematically identify and label their SOPs, and the document control should be described in its Quality Management Plan. Generally, each page of an SOP should have control documentation notation, similar to that illustrated below. A short title and identification (ID) number can serve as a reference designation. The revision number and date are very useful in identifying the SOP in use when reviewing historical data and is critical when the need for evidentiary records is involved and when the activity is being reviewed. When the number of pages is indicated, the user can quickly check if the SOP is complete. Generally this type of document control notation is located in the upper right-hand corner of each document page following the title page. Short Title/ID # Rev. #: Date: Page 1 of

PowerPoint Presentation:

CLEANING METHODS INTRODUCTION Cleaning is one of the major and critical activities in pharmaceutical operation. It is enough to say that clean environment and clean operations is the heart of pharmaceutical activities. The four basic requirements of cGMP are identity, safety, strength and purity. The concept of purity and safety are directly related to the cleaning operations. There are different levels or degrees of cleanliness required in pharmaceutical operations and naturally the specification of each of the cleaning will differ substantially. OBJECTIVES The major objective of cleaning methods is to avoid contamination of the pharmaceutical products or that contamination is reduced to an acceptable level. To confirm a reliable cleaning procedure so that the analytical monitoring may be omitted or reduced to a minimum in the routine phase.

PowerPoint Presentation:

OUTLINE OF A CLEANING METHOD Designing of a cleaning method is an important task. This process of designing includes What is being cleaned? e.g. Equipment, Facilities, Vessels and containers What are the contaminants? e g. Micro-organisms, Endotoxins , Dust and fibres What is the level of cleanliness expected and what is the acceptance criteria? Which cleaning agents to be used and at what concentration? Who is going to do the cleaning? Who is going to supervise? What record will be maintained? Once the data related to above points is collected then the required cleaning method may be adopted.

PowerPoint Presentation:

DIFFERENT METHODS OF CLEANING Manual cleaning procedures Semi-automated cleaning procedures Fully automated cleaning procedures Manual cleaning procedures are operator dependent. It however, does not mean that they are not effective, if these are carried out by properly trained operators, they could be superior to automated methods. But in the semi-automated and automated cleaning procedures, there is reduced operator involvement. However, this may not always be advantageous as the operator during manual cleaning can inspect the equipment at every step and may repeat the step if required. CLEANING ARRAY Equipment disassembly Prewash Wash Initial rinses Final rinse Reassembly

PowerPoint Presentation:

DOCUMENTATION FOR CLEANING The following aspects to be considered during the documentation of a cleaning procedure are:- Detailed cleaning procedure(s) are to be documented in SOPs. When more complex cleaning procedures are required, it is important to document the critical cleaning steps. Other factors such as history of cleaning, residue levels found after cleaning, and variability of test results may also dictate the amount of documentation required. The cleaning record should be signed by the operator who performed the cleaning and by the person responsible for Production and should be reviewed by Quality Assurance.

PowerPoint Presentation:

QUALITY CONTROL DOCUMENTATION INTRODUCTION Good documentation is an essential part of QA/QC system. It defines a system of information and control, so that misinterpretation or error in oral communications is minimized. OBJECTIVES To define the specifications of all materials. To prevent unambiguous procedures to be followed. To allow tracing of the batch history of any product. TYPES OF QC DOCUMENTS Quality manual Specifications and testing procedures For starting and packaging materials For intermediate and bulk products For finished products For containers and closures SOP’s and records

PowerPoint Presentation:

Quality Manual A quality manual is a documented quality system procedure intended for the overall planning and administration of activities which impacts quality within an organization. A quality manual should cover all the applicable elements of the quality system standards required for an organization. Purpose of quality manual Communicating the organization quality policy, procedures and requirements Describing and implementing effective quality system Providing the documented bases for auditing the quality system Quality policy - It is a statement made by the head of the organization on behalf of the organization, stating the organizations views and concern about quality.

PowerPoint Presentation:

2. Specifications and Testing Procedures Specification - A document describing in detail the requirements with which the product obtained during manufacture have to conform. Each specification should be approved and maintained by the quality control unit Periodic revisions of the specifications may be necessary to comply with new editions of the national pharmacopoeia or other official pharma compendia Testing procedures described in documents should be validated in context of available facilities and equipment before they are adopted for routine testing For starting and packaging materials The designated name and internal code reference; The reference, if any, to a pharmacopoeial monograph; and Qualitative and quantitative requirements with acceptance limits For intermediate and bulk products Specifications for intermediate and bulk products should be available if these are purchased or dispatched, or if data obtained from intermediate products are used in the evaluation of the finished product.

PowerPoint Presentation:

For finished products - The designated name of the product and the code reference where applicable; - The designated name(s) of the active ingredient(s) - A description of the dosage form and package details; - The qualitative and quantitative requirements, with acceptance limits; - The storage conditions and precautions, where applicable; and - The shelf-life. For containers and closures All containers and closures intended for use shall comply with the pharmacopeial requirements. Suitable validated test methods, sample sizes, specifications, cleaning procedure and sterilization procedure, where ever indicated, should be followed strictly to ensure that these are not reactive, additive, and adsorptive or leach and neither effects the quality or purity of the drugs.

PowerPoint Presentation:

Standard Operating Procedures (SOPs) and Records There should be standard operating procedures for the following: IPQC during packaging Change control system Complaint handling and Product recall Product recall Stability testing

PowerPoint Presentation:

REFERENCES 1. DOCUMENTATION RELATING TO PRODUCT DEVELOPMENT Pg: 166 & 247 of Q.A Manual by D.H Shah Pg: 206; 363 & 388 of How to practice GMP’s by P.P Sharma Pg: 339 of cGMP for Pharmaceuticals by Manohar A. Potdar www.robelle.com/library/papers/step/process.doc 2. STANDARD OPERATING PROCEDURES Pg: 255-259 of How to practice GMP’s by P.P Sharma SOP Guidelines by D.H Shah Pg: 377 of cGMP for Pharmaceuticals by Manohar A. Potdar http://www.epa.gov/QUALITY/qs-docs/g6-final.pdf http://www.mtnstopshiv.org/sites/default/files/attachments/SourceDocSOPv2.pdf 3. CLEANING METHODS Pg: 453 of cGMP for Pharmaceuticals by Manohar A. Potdar Pg: 79 of How to practice GMP’s by P.P Sharma SOP Guidelines by D.H Shah Pg: 70 of Q.A Manual by D.H Shah http://www.irjponline.com/admin/php/uploads/1205_pdf.pdf

PowerPoint Presentation:

4. QUALITY CONTROL DOCUMENTATION Pg: 230 of cGMP for Pharmaceuticals by Manohar A. Potdar Pg: 286 of How to practice GMP’s by P.P Sharma http://www.alspi.com/quality.pdf http://microcontacts.com/pdf/quality_manual.pdf http://www.optekinc.com/pdf/QualityManual.pdf

authorStream Live Help