Monday, December 6, 2010
E3: Structure and Content of Clinical Study Reports
Structure and content of clinical study report
The tripartite harmonised ICH guideline was finalised (Step 4) in November 1995. This document describes the format and content of a study report that will be acceptable in all three ICH regions. It consists of a core report suitable for all submissions and appendices that need to be available but will not be submitted in all cases.
E2F: Development Safety Update Report
Development Safety Update Report
The tripartite harmonised ICH guideline was finalised (Step 4) in August 2010.
The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.
The tripartite harmonised ICH guideline was finalised (Step 4) in August 2010.
The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.
E2E: Pharmacovigilance Planning
The tripartite harmonised ICH guideline was finalised (Step 4) in November 2004. This guideline is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug (in this guideline, the term "drug" denotes chemical entities, biotechnology-derived products, and vaccines). The main focus of this guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.
E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
Post approval safety data management
The Guideline was finalised, under Step 4 of the ICH process, on November 12, 2003. This document provides a standardized procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition. The practices of the data management were standardized in such cases obtained from consumers, literatures, internets which are all specific to post-approval data management. Good case management practice was focused and recommended for expedited reporting with clear definitions.
The Guideline was finalised, under Step 4 of the ICH process, on November 12, 2003. This document provides a standardized procedure for post-approval safety data management including expedited reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition. The practices of the data management were standardized in such cases obtained from consumers, literatures, internets which are all specific to post-approval data management. Good case management practice was focused and recommended for expedited reporting with clear definitions.
Guidelines for Engineering & Maintenance
1.0 Purpose : To provide guideline to ensure that different maintenance activities to support production are carried out in compliance with safety & cGMP requirement, at pre-determined frequency.
2.0 Objective : To provide documented guideline to ensure that different maintenance activities to support production are carried out in compliance with safety & cGMP requirement, at pre-determined frequency.
3.0 Scope : Scope of this SOP covers all the maintenance disciplines viz. mechanical, electrical & instrumentation as well as building maintenance.
4.0 Responsibility :
· Primary: Technician Engineering
· Secondary: Manager Engineering
5.0 Procedure :
- ORGANISATION & FUNCTION:
Ø The department must have a maintenance team that would perform all the maintenance functions meeting cGMP and good engineering requirements. It must also address to documentation, audits and training aspects pertaining to maintenance jobs.
Ø The Engineering Department organization must be structured to ensure that engineering functions are carried out safely, in accordance with cGMP requirements, efficiently and promptly to support production and other service areas. It must be resourced with adequate numbers of appropriately qualified and trained staff.
· MAINTENANCE STRATEGIES:
Ø Maintenance strategy must be in place for all equipments. It should consist of blend of planned (preventive) maintenance and corrective maintenance (history card).
Ø Corrective maintenance arises out of breakdowns and hence should be minimized / not repeated and filled history cards for each break down maintenance.
Ø A list must be prepared where all the equipment of the plant shall be listed. And that list would be duly reviewed by Production Manager, Engineering Manager, and General Manager and approved by QA Manager must be prepared.
Ø This list must indicate frequency of maintenance / calibration and tolerance as applicable.
· PREVENTIVE MAINTENANCE:
Ø Preventive maintenance for equipment must be scheduled on a basis appropriate for particular equipment – this should be based on statutory requirement, safety requirement, manufacturer’s recommendations, and history of the equipment.
Ø The frequency must be reviewed and changed for bringing-in improvement in performance of equipment and to build in reliability.
· CORRECTIVE MAINTENANCE:
Ø Corrective Maintenance must be carried out promptly to ensure that production down time is minimum. This shall be recorded in equipment history file.
Ø Nature of failures must be identified, understood and should be predictable. The preventive maintenance checklist must be amended by incorporating recommendations arising out of the investigation.
· PREVENTION OF CONTAMINATION AND CROSS CONTAMINATION:
Ø Prior to taking the equipment for maintenance, it must be cleaned by production staff.
Ø The post maintenance cleaning must address removal of replaced parts and materials, waste, cleaning materials and physical maintenance debris from the plant. The impact of maintenance operation such as footprints oils and greases must also be addressed.
Ø After the maintenance, the equipment, pipe, pipe fittings, etc. will be handed over to production for cleaning prior to its use. The adjacent clean equipment must be protected from contamination during maintenance operations on particular equipment
· BUILDING MAINTENANCE:
Ø Building maintenance shall be carried out as per statutory and site requirements. Documents like statutory records like painting of building, stability of building / structures etc. must be maintained to ensure that the building maintenance is carried out satisfactorily.
· VALIDATION:
Ø If maintenance service interfaces with other systems then the interfaces must be validated.
· CHANGE CONTROL:
Ø All changes must be fully documented, assessed and authorized prior to the work being carried out.
Ø In line with good documentation practice, the ELD (Engineering Line Diagram) should be updated to accurately reflect the as installed status following, a change as soon as is practicable after the change is implemented. Changes must be controlled as per the good engineering practices.
· TRAINING:
Ø All the staff shall be covered for cGMP, Safety and Job-related training as per the training procedure.
· STANDARD OPERATING PROCEDURES:
Ø Standard operating procedures must be prepared for all activities that are quality critical or safety critical or relate to key business areas. These SOPs must be prepared, reviewed & authorized and controlled in accordance with Site SOP.
Ø The SOPs must include specific maintenance instructions, lubrication details, Spares requirements, frequency of maintenance, responsibilities for carrying out the job & documentation, etc. as appropriate. The department activities must be reviewed to identify operations which need preparation of SOP and the current SOPs must be updated / reviewed as scheduled.
· AUDITS:
Ø Department audits must be carried out to monitor the Engineering aspects of departmental activities in regard to its impact on SHE, Energy Conservation and Quality matters.
· DOCUMENTATION:
Ø A separate list must be made for numbering and authorization of documents.
Ø The documents will include following:
R Forward Plan: A plan must be drawn-up for all equipment for routine maintenance as per the schedule and followed. In case of any deviation, it must be recorded and prior authorization obtained from appropriate Manager.
R Postponement of the schedule maintenance: Postponement of schedule maintenance for equipment may be required if, equipment can not be released for maintenance due production exigencies, Non-availability of external expert agency. Form requesting postponement of maintenance would be initiated by Production or Engineering Manager indicating reason for postponement and its impact and will be reviewed by Q.A. Manager and Authorized by G.M. (Works).
R Equipment file: Each equipment must have an equipment file. History of the equipment must be recorded in the equipment file. Maintenance checklist after carrying out preventive maintenance job must be filled up and filed in the Equipment history file.
R Check List: Check list must be prepared specific to each critical equipment indicating the job to be carried out. Check list will be of help to ensure that any item of maintenance has not been missed. However, the preventive maintenance checks shall not be limited to only what has been mentioned in it but surrounding site conditions must also be examined to ensure that the equipment continues to function as expected after the maintenance.
Validation Documents: Documentation pertaining to validation would include protocol and reports for DQ, IQ and OQ activities and would be in line with the Guidelines given. Protocols and reports must also include supplier’s documentation (e.g. pressure test, calibration certificate, etc.) besides the reports generated at site
Procedure For Restart The Activities After Power Failure / Breakdown
1.0 Purpose : To provide a documented procedure for Procedure For Restart The Activities After Power Failure / Breakdown
2.0 Objective : Procedure For Restart The Activities After Power Failure / Breakdown
3.0 Scope : This SOP is applicable for. Restart The Activities After Power Failure / Breakdown at -----Pharmaceuticals Ltd,
4.0 Responsibility :
· Primary: Technician Engineering
· Secondary: Manager Engineering
5.0 Procedure :
· Power failure:
Ø Check the main power circuit panel for voltage and break down.
Ø Start the D.G. Set and check the voltage and frequency, it should be 430 V and 50 HZ
Ø Then changeover the power supply from G.E.B. to D.G. Set for normal operation.
Ø After resuming the power supply from G.E.B. check the voltage and frequency.
Ø Before changing over power supply from D.G. Set power supply inform the critical
Ø Processing areas personnel and switch. the power supply for normal working.
· BREAKDOWN :
Ø In case of breakdown of power supply, confirm the nature of breakdown.
Ø Start the D.G. Set
Ø Check the voltage and frequency; it should be 430 V & 50 HZ.
Ø Change over the power supply from G.E.B. to D.G. Set for normal working.
Ø After attending the breakdown of power supply, restore the power supply and check the voltage and frequency of mains.
First Aid
1.0 Purpose : To provide a documented guideline for the first aid treatment
in case of any accident.
2.0 Objective : To provide a first aid treatment.
3.0 Scope : Employees / Visitors / workmen of agencies of ---- pharmaceutical Ltd,
4.0 Responsibility :
- Follow up : Officer Personnel & Administration
- Over all responsibility : General Manager (Adm).
5.0 Procedure :
· Training
Ø First aid training shall be given to selected employees of each department.
Ø Detail training of the first aid shall be given to some employees of the company.
Ø The list is as follows and shall be available in each department for easy reach out
during emergency.
| List of trained employees | ||
| Serial No. | Department | Name of Trained employees |
| | | |
| | | |
| | | |
| Format No. F/PA/001 | ||
· The first aid box shall be numbered and located at identified and marked
positions as following –
| Locations of first aid box | ||
| Serial No. | First aid box number | Location of First aid Box |
| | | |
| | | |
| Format No. F/PA/002 | ||
· Each first aid box shall contain following -
| Contents of first aid box | ||
| Serial No. | First Aid box Contents | Quantity |
| | | |
| | | |
| Format No. F/PA/003 | ||
· Every Monday from Personnel department personnel or General Manager (Adm) shall
Review the contents of first aid box and shall replenish the required item. The
Record of review shall be kept.
6.0 Reference documents
v List of trained employees
v Locations of first aid box
v Contents of first aid box
v Review of first aid box
· First aid box no ----------------
| Review of first aid box | |||||
| Date/day | Contents checked OK/not OK | Replenishment details | Reason for replenishment | Reviewed by | Discarded Items submitted to QA. |
| | | | | | |
| Format No. F/PA/004 | |||||
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