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COMPANY
The company we chose is pulse pharmaceuticals company (PVT) LTD.

LAB INTRODUCTION

Q.C Lab is specious, covering 900Sq/Ft area with three sections. The instrument section lab is well equipped with HPLC UV Spectrophotometer, Dissolution Test apparatus, Disintegration Apparatus, Refrectrometer, etc The analytical lab is furnished with necessary chemicals required for testing. The in process quality control section is directly involved in all process section check. The microbiological section is at developing stage

SERVICE OVERVIEW

Pulse PharmaIndustries is manufacturing Tablets and syrup. Rasco is manufacturer of Human product keeping in view the quality services into ailing humanity. Thus providing the standard medicine at reasonable prices. The antibiotic section of tablets, Capsule and Dry suspension has been approved from ministry of health and very soon production will be started.

Functions of quality department

JOB DESCRIPTION OF QUALITY CONTROL MANAGER REPORTING FUNCTIONS
Quality control Manager directly reports to the Plant Partner.

RESPONSIBILITIES AND AUTHORITIES

1. To arrange testing of raw materials. 2. To arrange testing of Bulk products. 3. To arrange testing of finished products. 4. To arrange calibration of instruments (internal and external both). 5. To trained the Analyst of the lab For Good Laboratory Practices. 6.To arrange microbiological testing of raw materials, products and finished products. 7. To develop testing methods of the products. 8. To arrange sampling of packing components, their testing and release. 9. To make system of In-process activities in production and warehouse. 10. To arrange stability studies of the products. 11. To arrange method validation, process validation. 12. To prepare training program for Chemists and Pharmacists for GLP & CGMP in Lab. 13. To maintain chemicals/glassware store. 14. To make SOPs of raw material, F/Products. 15. To make SOP of instruments, calibration, etc. 16. To maintain record of Q.C. retain samples. 17. Handling of complaints 18. Validation and calibration of production and Q.C. equipments. 19. Releases of the raw materials/packaging components/finished products. 20. Purchases of new instruments of Q.C. with the help of Production Manager

JOB DESCRIPTION OF ASSISTANT QUALITY CONTROL MANAGER REPORTING FUNCTIONS

Assistant Q.C Manager directly reports to the Q.C Manager.

RESPONSIBILITIES AND AUTHORITIES

1. To help the Q.C. Manager in analysis work. 2. To report to the officer concerned after completion of any job assigned. 3. To collecting sample of Raw Material, Packing Material and Products at various stages. 4. To get all the equipment/utensils and work-desk in order after completion of a particular job/test with the help of attendant. 5. To keep all of the reagents/chemical bottles/containers in order after completion of working with the help of attendant. 6. To work in other than routine duty if ask to do so. 7. To work in other than routine duty if ask to do so. 8. To make sure that whole of the section is in order regarding, cleanliness switch OFF and proper placing of all the equipment, chemicals and reagents utensils books and record files at completion of daily working. 9. Perform any duty assigned by the Quality Control Management according the skill of assistant 10. To perform the assigned duties of the Quality Control Manager in his/her absence under guidance of Director Technical.

INTRODUCTION
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations. Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society. Because "International Organization for Standardization" would have different acronyms in different languages ("IOS" in English, "OIN" in French for Organisation internationale de normalisation), its founders decided to give it also a short, all-purpose name. They chose "ISO", derived from the Greek isos, meaning "equal". Whatever the country, whatever the language, the short form of the organization's name is always ISO.

History

The organization which today is known as ISO began in 1926 as the International Federation of the National Standardizing Associations (ISA). This organization focused heavily on mechanical engineering. It was disbanded in 1942 during the second World War but was re-organized under the current name, ISO, in 1946. Even the name of the organization is standardized. The name, "ISO" is not an acronym but was derived from the Greek word "isos" meaning "equal". (The relation to standards is that if two objects meet the same standard, they should be equal.) This name eliminates any confusion that could result from the translation of "International Organization For Standardization" into different languages which would lead to different acronyms. ISO is a voluntary organization whose members are recognized standard authorities, each one representing one country. The bulk of the work of ISO is done by the 2700 technical committees, subcommittees and working groups. Each committee and subcommittee is headed by a Secretariat from one of the member organizations. The American National Standards Institute (ANSI) is the United States representative to ISO. The ANSI ASC Z1/ASQ Standards Group coordinates the United States representation in the ISO Technical Committees 176 and 207 which are concerned with the ISO 9000 and ISO 14000 standards respectively.

QUALITY MANAGEMENT SYSTEM ISO 9001 : 2000

General Requirements
Pulse Pharma establishes documents and maintains a Quality Management System and continually improves its effectiveness in accordance with the requirements of this International Standard. Pulse Pharma: a) b) c) d) e) f) Identify process needs for the Quality Management System and the application throughout the Organization. Determine the sequence and interaction of process Determine the method and criteria to monitor the operation and process effectiveness. Ensure the availability of resources Monitor, measure and analysis of process Implement actions to achieve planned results and continue improvement of process. Pulse Pharma identifies and maintains the control over process, which are conducted, outsource. For reference, see process flow chart and work instruction.

Documentation Requirement General

Quality Management System Documentation of Pulse Pharma includes, a) b) c) Document statement of Policy and Objectives. Quality Manual Procedure

8 d) e) Documents to ensure the planning, operation and control of its process, Quality records required.

Quality Manual
Pulse Pharma establishes and maintains a quality manual that includes: a) Scope of Quality Management System, details or justification of any exclusion. b) Procedure or reference c) Description between process and Quality Management System

Control of Documents
Pulse Pharma controls all the documents required by Quality Management System. This control is consists of: a) b) c) d) e) f) g) h) Approve the documents for prior to issue. Review and update s necessary and re approved Ensure that changes and the current revision status are identified. Ensure that relevant version of documents are available at point of use. Ensure that documents are legible and identified Ensure that documents of external origin are identified and distribution is controlled. Prevent the obsolete documents. Retention time, which is minimum to at least the life of services.

Control of Quality Records

Pulse Pharma establishes and maintains procedure for Quality Records to provide evidence of conformity to requirements and of the effective operation of Quality Management System. This procedure defines the control for identification, storage, protection, retrieval, retention time and disposition of quality records for each batch for traceability.

Specific Requirements
SCOPE
PULSE PHARMACEUTICALS (PVT.) LTD.. has established, documented, implemented and maintained a procedure for the quality management system applied throughout the organization.

APPLICABILITY
This procedure is applied on all the sections, branches, departments and juristic area of PULSE PHARMACEUTICALS (PVT.) LTD...

RESPONSIBILITY
It is the responsibility of all key persons of PULSE PHARMACEUTICALS (PVT.) LTD.. Organization specially the CEO to document, implement and revise this procedure as required day by day.

ABBREVIATION
   QP = MRC = SOP = Quality Procedure. Management Review Committee. Standard Operating Procedure.

PROCEDURE
 MRC of PULSE PHARMACEUTICALS (PVT.) LTD.. has listed below her all the processes for quality management system and their critical points for product conformity.  Resources  Purchase  Product Realization: Tablets Capsule Dry Syrup  Identification:  Inspection & Testing:

10 Lab. Equipment Calibration List of Equipments With Maintenance Schedule Weighing Machine Reference Sample Till date of expiry Communication + Documentation Storage: Packing + Labeling: Delivery: Marketing + Capability Analysis Customer Feedback: Records Keeping:

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RELATED DOCUMENT
 All Quality Documents

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Implementation and problems in implementation

pulse pharmaceutical company implemented the iso standard in its following departments a) b) c) d) production department Quality control department Marketing department Sales Department

They implemented the iso standards in the procedures and processes involved in these departments since they are registered with the international standard organization ,dated 21 march 2007.

Problems in implementation
The basic problems in implementation are the workers of the pulse pharmaceutical company.they resist to implement the iso quality standard because they paid low and they have to work hard to implement these standards.they have no know how about these standards.

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Cost and benefit and analysis of the iso implementation Cost

The cost for registration to iso is 60,000 PKR.

Benefits
1. IT helps to improve our image to export our products in European countries 2. Customer satisfaction 3. Profit increases upto 120,000 PKR 4. Expansion in local market share upto 35% 5. Increase in number of contracts received

Analyisis
In overall analysis the company gain a lot of benefits as compared to cost beared in implementing iso quality standarsds.

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CONTROL OF DOCUMENTATION
SCOPE
PULSE PHARMACEUTICALS (PVT.) LTD.. has established, documented, implemented and maintained a procedure for the documentation requirements, quality manual, and control of document and control of records.

APPLICABILITY
This procedure is applied on all quality documents, forms and records including obsolete records.

RESPONSIBILITY
It is the responsibility of MR to maintain and control all the documentations.

ABBREVIATIONS
      QP MRC SOP CEO/DP M.R ADMIN = = = = = Quality Procedure. Management Review Committee. Standard Operating Procedures. Chief Executive Officer / Director Production Manager Representative / Q.C. Manager = Administrator

PROCEDURE
QUALITY POLICY STATEMENT Our commitment is to produce excellent quality medicine at low price for the customer satisfaction with effective resources through skilled professionals,, the excellence of work and continues improvement.

QUALITY OBJECTIVES
PULSE PHARMACEUTICALS (PVT.) LTD.. has two types of objectives: 1. Long term Objectives

14 2. Short term Objectives All these objectives are initiated during the MRC meeting. All these objective are planned, executed, checked, verified and discussed during MRC meeting. Quality objective form is used for this purpose. QUALITY MANUAL The Quality Manual is current and up-to-date to reflect changes to the system and approved by CEO by signing on title Page of Quality Manual. It is simply stated, easy to use, and fully approved by all affected functional groups. All the revision record & mentioned on 3rd page of Quality Manual. PULSE PHARMACEUTICALS (PVT.) LTD.. has its policy for each element of ISO 9001:2000 Standards in the Quality Manual. For each element, as appropriate, PULSE PHARMACEUTICALS (PVT.) LTD.. has documented procedures that further describe how the specific policy objectives and goals are met. The Quality Manual includes these documented procedures. Where applicable, SOPs are also included in the quality manual. Quality procedures and SOPs are implemented as written. The procedures explain how PULSE PHARMACEUTICALS (PVT.) LTD.. implements the requirements of ISO 9001:2000 in accordance with its Quality Policy. These are revised, as necessary, to reflect the actual objectives, flow of tasks, and staff responsibilities

DOCUMENT STRUCTURE
LEVEL I Quality Policy Manual, LEVEL II Quality Procedures, LEVEL III Standard Operating Procedures/Work Instructions LEVEL IV Forms (Records). Approval: All the levels are discussed in MRC meeting and CEO / DP has signed for approval at title page of Quality Manual.

CONTROL OF DOCUMENTS
PULSE PHARMACEUTICALS (PVT.) LTD.. maintains four-quality documentation: Quality Manual, Quality Procedures, SOPs/work Instruction and Forms (Records).
QUALITY MANUAL (LEVEL I)

Quality Manual is identified and controlled by its revision No, effective Date, Title and Level. Distribution of Quality Manual is also recorded on title page of the manual and the Document Distribution List showing the distribution destination.
REVISION

a)

When the number of changes exceeding 100 or when decided by Management Review Committee, a new issue of the manual is promulgated to all distribution points.

15 b) A CPA (Occur by Audit, Customer Feedback, Management Review Committee, Corrective / Preventive Action) is raised for any change made at any page in Quality Manual changed matter is underlined. Management Representative makes approval by signing the CPA.

c)

QUALITY PROCEDURES (LEVEL II)

Quality Procedures are identified and controlled by its revision No, effective Date, Title and QP No. Distribution of Quality Procedures is recorded on the Distribution List showing the distribution destination.

SOP (LEVEL III)

SOPs / Work Instructions are identified and controlled by their Revision No, Effective Date, Title and SOP No./Work Instruction No. Distribution of SOPs is recorded on respective SOPs and SOPs list and Distribution on first page of level iii showing the distribution destination.
REVISION

A single change in any SOP will change the revision no and Effective date.

FORMS (RECORDS) (LEVEL IV)

Forms are identified and controlled by their revision No, doc# and Title. All the records are maintained on Document record Master List. Numbering Scheme Each form is assigned a unique Doc # showing the abbreviation of concerned procedure / level of doc / serial No. e.g. CPD/04/01 where CPD shows concerned procedure that is control of production, 04 shows level of document and 01 shows serial No. of form used in that particular procedure. ABRIVIATION. Following abbreviations are used for different procedures. Management Committee. MGT. Control Of Documentation COD Resource Management. RM Customer. CRP Purchasing PUR Control of Production. CPD Trace Ability TCR Preservation. WH

16 Calibration. Analysis of Data Internal Quality Audit. Monitor and Measurement. Corrective Preventive Action. Improvements. REVISION. Q.C ADT IQA. CLB. CPA. IMP.

A single change in any forms will change the revision no.

CONTROL OF OBSOLETE DOCUMENTS RETENTION

Obsolete documents are retained stapled with the concerned CPA or reference of CPA no. and are retained for the period equivalent to the life of the Products which is defined on Document record Master List. IDENTIFICATION Any quality document or a portion thereof when obsolete is stamped Obsolete HANDLING Obsolete documents are withdrawn from all concerned points by replacing the current documents by MR himself and these obsolete documents are placed in Obsolete Documents File duly attached with a copy of respective CPA. EXTERNAL ORIGIN. Documents are identified with a stamp External Origin and distribution is identified and controlled on Document Master List.

CONTROL OF RECORDS
PULSE PHARMACEUTICALS (PVT.) LTD.. maintains Quality Records. All the records are identified and controlled on Document record Master List details the retention site or location, Doc # if it is used for record and retention time for quality records. Quality records for each batch / lot are also maintained in separate file for each batch / lot.).

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IDENTIFICATION
Quality Documents/ records are stored in a common location area (Quality Records) as identified on the Quality Documents Master List. The common location is communicated to each individual in the area and the location is clearly marked as Quality Documents/ Records.

STORAGE
All the quality Documents records are stored in a common location area clearly marked as Quality Records and no unauthorized person has the access to the store.

PROTECTION
All quality records are maintained / locked by MR / Q.C. Manager. No unauthorized person has the access to the store. DOCUMENT CHANGE Any kind of change in documents can be raised from any employee through corrective Preventive Action Report.

RETRIEVAL
All quality system records once generated and completed, come to MR / Q.C. Manager.

RETENTION TIME
Retention time is mentioned on Document Record Master List.

DISPOSITION
All expired quality records are disposed (Recycling Agency) by MR / Q.C. Manager with concern of production Manager. RELATED DOCUMENT        All Levels of Quality Manual Corrective Preventive Action Report. Document Record Master List. All other quality documents Quality Objective Form Doc. Distribution List. External Origin Document

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INTERNAL AUDIT
SCOPE
PULSE PHARMACEUTICALS (PVT.) LTD.. has established, documented, implemented and maintained a procedure for Internal Audit, Monitor and Measurement of process.

APPLICABILITY
This procedure is applied on analysis of production and quality system.

RESPONSIBILITY
Responsibilities are defined in procedure.

ABBREVATION
    QP MR PM CPA = = = = Quality Procedure Management Representative Production Manager Corrective/preventive action.

INTERNAL AUDIT PROCEDURE AUDIT PLAN

The internal quality audits are conducted once in 6 Months on the plan developed by the Management Representative. Each procedure area within the Quality Manual is included in the Internal Audit Plan. The individuals assigned to conduct the audits are determined by the Management Representative and are identified in the audit plan. The identified auditors are independent of the area being audited. Production Manager when assigned to conduct an audit; he may arrange trained external auditors/consultant.

INTERNAL AUDIT CHECKLIST

Internal audit checklist is issued to conduct internal audit and is maintained by MR. The designated auditor uses only the particular portion of the checklist intended for the areas by audited.

AUDIT FREQUENCY
Internal audit will be conducted twice in a year or when needed by management.

SECOND PARTY AUDIT.

19 Customer has the access to audit production, equipment and training areas and other areas covered by this manual with the permission of M.P. M.P. if not satisfied with internal audit can have the services of consultant for complete audit for the areas under the direct responsibility of MR.

CONDUCT AUDITS AND RECORD CORRECTIVE ACTIONS

The quality process audits are conducted in each area. The Management Representative reviews the non-conformities and he decides corrective action in consultation with the relevant department. All non-conformities are reported and corrective actions taken on the Non-Conformity Report (CPA).

CLOSING OF CPAS
All corrective actions are agreed between auditor and auditee. A target completion date is also agreed for taking the c corrective/preventive actions with in stipulated date. If a corrective/preventive action (CPA) is not taken and verified with in target date, a new CPA is raised and a new target date is fixed for respective CPA. But root cause for not taking the corrective/preventive actions within agreed period is found and preventive actions are taken. REPORT AUDIT RESULTS Internal audit reports are used for reporting the audit results. Which is also recommended by Production Manager. MONITOR AND MEASUREMENT OF PROCESS PULSE PHARMACEUTICALS (PVT.) LTD.. conduct Internal Audit for monitor and measurement of process. This method demonstrates the ability of the processes to achieve planned results. If results are not achieved, PULSE PHARMACEUTICALS (PVT.) LTD.. takes relevant corrective action to ensure the conformity of product. RELATED DOCUMENT     Internal Audit Plan Internal Audit checklist CPA Internal Audit Report

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EXTERNAL AUDIT
External audit done by a team composed of 5 members .they have found following lacks in quality department which are as follows. 1) 2) 3) 4) 5) Lack of emergency box(first aid box) Lack of employees record Lack of written proper records Insufficient ventilation system Lack of proper documentation of customer feed back

Auditor advised tha next time try to improve these deficiencies

Audit conducted on 31 dec 2009

Reference
Information received by MR.ZAKIR who is QC manager of Pulse Pharamacuetical company