QualityGuidances

1.0   OBJECTIVE

To lay down the Procedure for preparation of  Job Responsibilities.

• SCOPE

This Procedure is applicable to provide the guidelines for preparation of Job Responsibilities

• RESPONSIBILITY

All Departments shall be responsible for follow the procedure mention in this SOP.

• ACCOUNTABILITY

QA Head shall be accountable for compliance of this SOP.

• ATTACHMENTS

Organogram                                                        –           Attachment-I

Employee Profile                                                –           Attachment-II

Job Responsibilities                                            –           Attachment-III

• PROCEDURE
  • To maintain a satisfactory system of Quality Assurance and manufacturing of drug product, as per cGMP requirement. Total operation is divided into various functions, called as Departments. Following are the departments :
    • Warehouse
    • Production
    • Engineering & Utility
    • Quality Control
    • Quality Assurance
    • Personnel & Administration
  • Each department shall be provided with defined responsibility to perform the task for manufacturing of tablet, capsule, oral Liquid and dry syrup to meet cGMP requirement.
  • The duties of each department are defined but not necessarily be limited to as follows.
  • Warehouse
    • Preparation and review of the instruction for describing the receipt, identification, quarantine, storage and handling of raw materials/ Packing   materials/Finished product.
    • Receipt, identification, quarantine, storage and handling of material / product according to pre approved instructions.
    • Environmental monitoring of the area as per predefined procedures.
    • Making sure that any deviation is reported and investigated properly.
    • Making sure that storage area is cleaned.
    • Inventory control.
  • Production
    • Preparing and reviewing the instructions for the production of products according to written procedures.
    • Producing products according to pre-approved instructions.
    • Reviewing all production batch records and ensuring that are completed and signed.
    • Making sure that all production deviations are reported and evaluated and that critical deviations are investigated and conclusions are recorded.
    • Make sure that productions facilities are clean and disinfected when appropriate.
    • Making sure that the necessary calibrations are performed and recorded in respective areas.
    • Making sure that the premises and equipment are maintained and recorded in respective areas.
    • Evaluation of proposed changes in product, process or equipment.
    • Making sure that new and when appropriate, modified facilities and equipment are qualified.
  • Engineering & Utility
    • Preparation and review of the instruction for describing the procedure for preventive maintenance, breakdown maintenance.
    • Evaluating any change in equipment, machinery.
    • Operation of all Utilities like Water, HVAC, Boiler, Compressed Air etc.
    • Execution of Installation and Operational Qualification of equipment as per approved protocol.
  • Quality Control
    • Approve / Reject of raw material / Packing Material/Finished Product.
    • In process Control of product quality.
    • Making sure that critical deviations are investigated and resolved.
    • Out of Specification Investigation.
    • Preparation and Standardization of volumetric solutions and reagents.
    • Inventory control of chemicals / Glassware etc.
    • Preparation and review of all SOP’s related to department, Specification and test procedures.
    • Initiation and review of any change related to the department.
    • Preparation and execution of validation protocol for method validation.
    • Making sure that materials are appropriately tested and results are reported.
    • To conduct Stability Studies.
    • Calibration of instruments used in the Laboratories.
    • Handling of Reference standard and Working standard and qualification of working standard.
    • Quality control department shall be responsible for issue, control, review and retrieval of worksheets.
  • Quality Assurance

6.8.1  To formulate systems for the implementation of cGMP and to ensure the preparation, approval and implementation  of  Standard   Operating   Procedures, Standard  Cleaning Procedures, Specifications, Standard Test Procedures, Cleaning validation protocols, stability protocols, Master Batch Production records, etc.,

6.8.2 To evaluation and qualification of vendors of raw material and packaging material.

6.8.3 Quality Assurance department shall be responsible for sampling the in-process materials, finished                          products and stability samples.

• Quality Assurance department shall be responsible to review and approve validation protocols, to review changes in product processes, equipments, or any other changes as per SOP “Change Control”.
• Quality Assurance department shall be responsible to check dispensing of materials and for in-process quality control.
• Quality Assurance department shall be responsible to release the batch after reviewing the Batch Production records to assure that the batch has been manufactured as per the Master Batch Production Record and there are no deviations, if any, are recorded and authorised.
• Quality Assurance department shall be responsible for auditing methods, results, systems and processes and for performing the trend analysis and preparation of annual review of drug product quality.
• Quality Assurance department shall be responsible to release the finished products and to maintain the reserve samples of finished product and batch production and control records.
• Quality Assurance department shall be responsible to investigate market complaints and to maintain market complaints investigation records.
• Quality Assurance department shall be responsible for disposition of Incidents/OOS and approval of deviations.
• Quality Assurance department shall be responsible for monitoring of stability studies.
• Quality Assurance personnel shall be trained as per the SOP “Training of Employees”

• Personnel & Administration
  • To prepare procedure for personnel hygiene medical checkup, housekeeping.
  • Employee Welfare.
  • To coordinate for training to all employees.
  • To conduct regular medical checkups and housekeeping.

6.9.5 The department head shall ensure that adequate number of personnel with necessary qualification and      experience are provided to complete the departmental responsibility.

6.9.6  An Organogram for each department shall be prepared by department head/or his designee and approved      by Head of the Department and QA Head as per Attachment-I.

6.9.7 The individual employee profile shall be prepared and approved by Head of the Department as per Attachment-II and revised after two years.

6.9.8  The individual job responsibilities shall be prepared by Department Head and shall be approved by Head-QA as per Attachment-III and revised after two years or hen job responsibilities are revised.

• REFERENCES:

In House

• ABBREVIATIONS

SOP             –  Standard Operating System

QA              –  Quality Assurance

cGMP          – Current Good Manufacturing Practices

STP              – Standard Test Procedure

• DISTRIBUTION LIST

          Quality Assurance

Quality Control

Production

Engineering & Utility

Personnel & Administration

Warehouse

 

10.0   HISTORY OF REVISION:

Version No.	Effective Date	Reason for Revision