ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL

1 Introduction 

Essential Documents are those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.

Essential Documents also serve a number of other important purposes. Filing essential documents at the investigator/institution and sponsor sites in a timely manner can greatly assist in the successful management of a trial by the investigator, sponsor and monitor. These documents are also the ones which are usually audited by the sponsor’s independent audit function and inspected by the regulatory authority(ies) as part of the process to confirm the validity of the trial conduct and the integrity of data collected.

The minimum list of essential documents which has been developed follows. The various documents are grouped in three sections according to the stage of the trial during which they will normally be generated: 1) before the clinical phase of the trial commences, 2) during the clinical conduct of the trial, and 3) after completion or termination of the trial. A description is given of the purpose of each document, and whether it should be filed in either the investigator/institution or sponsor files, or both. It is acceptable to combine some of the documents, provided the individual elements are readily identifiable.

Trial master files should be established at the beginning of the trial, both at the investigator/institution’s site and at the sponsor’s office. A final close-out of a trial can only be done when the monitor has reviewed both investigator/institution and sponsor files and confirmed that all necessary documents are in the appropriate files.

Any or all of the documents addressed in this guideline may be subject to, and should be available for, audit by the sponsor’s auditor and inspection by the regulatory authority(ies).

 2 Before the Clinical Phase of the Trial Commences 

During this planning stage the following documents should be generated and should be on file before the trial formally starts

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
2.1	INVESTIGATOR’S BROCHURE	To document that relevant and current scientific information about the investigational product has been provided to the investigator	X	X
2.2	SIGNED PROTOCOL AND AMENDMENTS, IF ANY, AND SAMPLE CASE REPORT FORM (CRF)	To document investigator and sponsor agreement to the protocol/amendment(s) and CRF	X	X
2.3	INFORMATION GIVEN TO TRIAL SUBJECT - INFORMED CONSENT FORM (including all applicable translations)	To document the informed consent	X	X
	- ANY OTHER WRITTEN INFORMATION	To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully informed consent	X	X
	- ADVERTISEMENT FOR SUBJECT RECRUITMENT (if used)	To document that recruitment measures are appropriate and not coercive	X
2.4	FINANCIAL ASPECTS OF THE TRIAL	To document the financial agreement between the investigator/institution and the sponsor for the trial	X	X
	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
2.5	INSURANCE STATEMENT (where required)	To document that compensation to subject(s) for trial-related injury will be available	X	X
2.6	SIGNED AGREEMENT BETWEEN INVOLVED PARTIES, e.g.: - investigator/institution and sponsor - investigator/institution and CRO - sponsor and CRO - investigator/institution and authority(ies) (where required)	To document agreements	X X X	X X (where required) X X
2.7	DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING: - protocol and any amendments - CRF (if applicable) - informed consent form(s) - any other written information to be provided to the subject(s) - advertisement for subject recruitment (if used) - subject compensation (if any) - any other documents given approval/ favourable opinion	To document that the trial has been subject to IRB/IEC review and given approval/favourable opinion. To identify the version number and date of the document(s)	X	X

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
2.8	INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION	To document that the IRB/IEC is constituted in agreement with GCP	X	X (where required)
2.9	REGULATORY AUTHORITY(IES) AUTHORISATION/APPROVAL/ NOTIFICATION OF PROTOCOL (where required)	To document appropriate authorisation/approval/notification by the regulatory authority(ies) has been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s)	X (where required)	X (where required)
2.10	CURRICULUM VITAE AND/OR OTHER RELEVANT DOCUMENTS EVIDENCING QUALIFICATIONS OF INVESTIGATOR(S) AND SUB-INVESTIGATOR(S)	To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects	X	X
2.11	NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/TECHNICAL PROCEDURE(S) AND/OR TEST(S) INCLUDED IN THE PROTOCOL	To document normal values and/or ranges of the tests	X	X
2.12	MEDICAL/LABORATORY/TECHNICAL PROCEDURES /TESTS - certification or - accreditation or - established quality control and/or external quality assessment or - other validation (where required)	To document competence of facility to perform required test(s) , and support reliability of results	X (where required)	X
	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
2.13	SAMPLE OF LABEL(S) ATTACHED TO INVESTIGATIONAL PRODUCT CONTAINER(S)	To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects		X
2.14	INSTRUCTIONS FOR HANDLING OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS (if not included in protocol or Investigator’s Brochure)	To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials	X	X
2.15	SHIPPING RECORDS FOR INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS	To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability	X	X
2.16	CERTIFICATE(S) OF ANALYSIS OF INVESTIGATIONAL PRODUCT(S) SHIPPED	To document identity, purity, and strength of investigational product(s) to be used in the trial		X
2.17	DECODING PROCEDURES FOR BLINDED TRIALS	To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects’ treatment	X	X (third party if applicable)

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
2.18	MASTER RANDOMISATION LIST	To document method for randomisation of trial population		X (third party if applicable)
2.19	PRE-TRIAL MONITORING REPORT	To document that the site is suitable for the trial (may be combined with  2.20)		X
2.20	TRIAL INITIATION MONITORING REPORT	To document that trial procedures were reviewed with the investigator and the investigator’s trial staff ( may be combined with  2.19)	X	X

 3 During the Clinical Conduct of the Trial 

In addition to having on file the above documents, the following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available

3.1

INVESTIGATOR’S BROCHURE UPDATES

To document that investigator is informed in a timely manner of relevant information as it becomes available

X

X

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
3.2	ANY REVISION TO: - protocol/amendment(s) and CRF - informed consent form - any other written information provided to subjects - advertisement for subject recruitment (if used)	To document revisions of these trial related documents that take effect during trial	X	X
3.3	DATED, DOCUMENTED APPROVAL/FAVOURABLE OPINION OF INSTITUTIONAL REVIEW BOARD (IRB) /INDEPENDENT ETHICS COMMITTEE (IEC) OF THE FOLLOWING: - protocol amendment(s) - revision(s) of: - informed consent form - any other written information to be provided to the subject - advertisement for subject recruitment (if used) - any other documents given approval/favourable opinion - continuing review of trial (where required)	To document that the amendment(s) and/or revision(s) have been subject to IRB/IEC review and were given approval/favourable opinion. To identify the version number and date of the document(s).	X	X

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
3.4	REGULATORY AUTHORITY(IES) AUTHORISATIONS/APPROVALS/NOTIFICATIONS WHERE REQUIRED FOR: - protocol amendment(s) and other documents	To document compliance with applicable regulatory requirements	X (where required)	X
3.5	CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB-INVESTIGATOR(S)	(see  2.10)	X	X
3.6	UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR MEDICAL/ LABORATORY/ TECHNICAL PROCEDURE(S)/TEST(S) INCLUDED IN THE PROTOCOL	To document normal values and ranges that are revised during the trial (see  2.11)	X	X
3.7	UPDATES OF MEDICAL/LABORATORY/ TECHNICAL PROCEDURES/TESTS - certification or - accreditation or - established quality control and/or external quality assessment or - other validation (where required)	To document that tests remain adequate throughout the trial period (see  2.12)	X (where required)	X
3.8	DOCUMENTATION OF INVESTIGATIONAL PRODUCT(S) AND TRIAL-RELATED MATERIALS SHIPMENT	(see  2.15.)	X	X

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
3.9	CERTIFICATE(S) OF ANALYSIS FOR NEW BATCHES OF INVESTIGATIONAL PRODUCTS	(see  2.16)		X
3.10	MONITORING VISIT REPORTS	To document site visits by, and findings of, the monitor		X
3.11	RELEVANT COMMUNICATIONS OTHER THAN SITE VISITS - letters - meeting notes - notes of telephone calls	To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting	X	X
3.12	SIGNED INFORMED CONSENT FORMS	To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (see  2.3)	X
3.13	SOURCE DOCUMENTS	To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject	X

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
3.14	SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)	To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded	X (copy)	X (original)
3.15	DOCUMENTATION OF CRF CORRECTIONS	To document all changes/additions or corrections made to CRF after initial data were recorded	X (copy)	X (original)
3.16	NOTIFICATION BY ORIGINATING INVESTIGATOR TO SPONSOR OF SERIOUS ADVERSE EVENTS AND RELATED REPORTS	Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with 4.11	X	X
3.17	NOTIFICATION BY SPONSOR AND/OR INVESTIGATOR, WHERE APPLICABLE, TO REGULATORY AUTHORITY(IES) AND IRB(S)/IEC(S) OF UNEXPECTED SERIOUS ADVERSE DRUG REACTIONS AND OF OTHER SAFETY INFORMATION	Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in accordance with 5.16.2 and 4.11.2	X (where required)	X
3.18	NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION	Notification by sponsor to investigators of safety information in accordance with 5.16.2	X	X
3.19	INTERIM OR ANNUAL REPORTS TO IRB/IEC AND AUTHORITY(IES)	Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3	X	X (where required)
	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
3.20	SUBJECT SCREENING LOG	To document identification of subjects who entered pre-trial screening	X	X (where required)
3.21	SUBJECT IDENTIFICATION CODE LIST	To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject	X
3.22	SUBJECT ENROLMENT LOG	To document chronological enrolment of subjects by trial number	X
3.23	INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE	To document that investigational product(s) have been used according to the protocol	X	X
3.24	SIGNATURE SHEET	To document signatures and initials of all persons authorised to make entries and/or corrections on CRFs	X	X
3.25	RECORD OF RETAINED BODY FLUIDS/ TISSUE SAMPLES (IF ANY)	To document location and identification of retained samples if assays need to be repeated	X	X

 4 After Completion or Termination of the Trial 

After completion or termination of the trial, all of the documents identified in sections  2 and  3 should be in the file together with the following

	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
4.1	INVESTIGATIONAL PRODUCT(S) ACCOUNTABILITY AT SITE	To document that the investigational product(s) have been used according to the protocol. To documents the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor	X	X
4.2	DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION	To document destruction of unused investigational products by sponsor or at site	X (if destroyed at site)	X
4.3	COMPLETED SUBJECT IDENTIFICATION CODE LIST	To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a confidential manner and for agreed upon time	X
4.4	AUDIT CERTIFICATE (if available)	To document that audit was performed		X
4.5	FINAL TRIAL CLOSE-OUT MONITORING REPORT	To document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files		X
4.6	TREATMENT ALLOCATION AND DECODING DOCUMENTATION	Returned to sponsor to document any decoding that may have occurred		X
	Title of Document	Purpose	Located in Files of
			Investigator/ Institution	Sponsor
4.7	FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)	To document completion of the trial	X
4.8	CLINICAL STUDY REPORT	To document results and interpretation of trial	X (if applicable)	X

CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)

The contents of a trial protocol should generally include the following topics. However, site specific information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure.

6.1 General Information 
6.1.1 Protocol title, protocol identifying number, and date. Any amendment(s) should also bear the amendment number(s) and date(s).
6.1.2 Name and address of the sponsor and monitor (if other than the sponsor).
6.1.3 Name and title of the person(s) authorized to sign the protocol and the protocol amendment(s) for the sponsor.
6.1.4 Name, title, address, and telephone number(s) of the sponsor’s medical expert (or dentist when appropriate) for the trial.
6.1.5 Name and title of the investigator(s) who is (are) responsible for conducting the trial, and the address and telephone number(s) of the trial site(s).
6.1.6 Name, title, address, and telephone number(s) of the qualified physician (or dentist, if applicable), who is responsible for all trial-site related medical (or dental) decisions (if other than investigator).
6.1.7 Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the trial.

6.2 Background Information 
6.2.1 Name and description of the investigational product(s).
6.2.2 A summary of findings from nonclinical studies that potentially have clinical significance and from clinical trials that are relevant to the trial.
6.2.3 Summary of the known and potential risks and benefits, if any, to human subjects.
6.2.4 Description of and justification for the route of administration, dosage, dosage regimen, and treatment period(s).
6.2.5 A statement that the trial will be conducted in compliance with the protocol, GCP and the applicable regulatory requirement(s).
6.2.6 Description of the population to be studied.
6.2.7 References to literature and data that are relevant to the trial, and that provide background for the trial.

6.3 Trial Objectives and Purpose A detailed description of the objectives and the purpose of the trial. 

6.4 Trial Design The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design. 
A description of the trial design, should include:
6.4.1 A specific statement of the primary endpoints and the secondary endpoints, if any, to be measured during the trial.
6.4.2 A description of the type/design of trial to be conducted (e.g. double-blind, placebo-controlled, parallel design) and a schematic diagram of trial design, procedures and stages.
6.4.3 A description of the measures taken to minimize/avoid bias, including: (a) Randomization. (b) Blinding.
6.4.4 A description of the trial treatment(s) and the dosage and dosage regimen of the investigational product(s). Also include a description of the dosage form, packaging, and labelling of the investigational product(s).
6.4.5 The expected duration of subject participation, and a description of the sequence and duration of all trial periods, including follow-up, if any.
6.4.6 A description of the “stopping rules” or “discontinuation criteria” for individual subjects, parts of trial and entire trial.
6.4.7 Accountability procedures for the investigational product(s), including the placebo(s) and comparator(s), if any.
6.4.8 Maintenance of trial treatment randomization codes and procedures for breaking codes.
6.4.9 The identification of any data to be recorded directly on the CRFs (i.e. no prior written or electronic record of data), and to be considered to be source data.

6.5 Selection and Withdrawal of Subjects 

6.5.1 Subject inclusion criteria.
6.5.2 Subject exclusion criteria.
6.5.3 Subject withdrawal criteria (i.e. terminating investigational product treatment/trial treatment) and procedures specifying:
(a) When and how to withdraw subjects from the trial/ investigational product treatment.
(b) The type and timing of the data to be collected for withdrawn subjects.
(c) Whether and how subjects are to be replaced.
(d) The follow-up for subjects withdrawn from investigational product treatment/trial treatment.

6.6 Treatment of Subjects 
6.6.1 The treatment(s) to be administered, including the name(s) of all the product(s), the dose(s), the dosing schedule(s), the route/mode(s) of administration, and the treatment period(s), including the follow-up period(s) for subjects for each investigational product treatment/trial treatment group/arm of the trial.
6.6.2 Medication(s)/treatment(s) permitted (including rescue medication) and not permitted before and/or during the trial.
6.6.3 Procedures for monitoring subject compliance.

6.7 Assessment of Efficacy 
6.7.1 Specification of the efficacy parameters.
6.7.2 Methods and timing for assessing, recording, and analysing of efficacy parameters.

6.8 Assessment of Safety 
6.8.1 Specification of safety parameters.
6.8.2 The methods and timing for assessing, recording, and analysing safety parameters.
6.8.3 Procedures for eliciting reports of and for recording and reporting adverse event and intercurrent illnesses.
6.8.4 The type and duration of the follow-up of subjects after adverse events.

6.9 Statistics 
6.9.1 A description of the statistical methods to be employed, including timing of any planned interim analysis(ses).
6.9.2 The number of subjects planned to be enrolled. In multicentre trials, the numbers of enrolled subjects projected for each trial site should be specified. Reason for choice of sample size, including reflections on (or calculations of) the power of the trial and clinical justification.
6.9.3 The level of significance to be used.
6.9.4 Criteria for the termination of the trial.
6.9.5 Procedure for accounting for missing, unused, and spurious data.
6.9.6 Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in protocol and/or in the final report, as appropriate).
6.9.7 The selection of subjects to be included in the analyses (e.g. all randomized subjects, all dosed subjects, all eligible subjects, evaluable subjects).

6.10 Direct Access to Source Data/Documents. 
The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data/documents.

6.11 Quality Control and Quality Assurance
6.12 Ethics Description of ethical considerations relating to the trial. 
6.13 Data Handling and Record Keeping
6.14 Financing and Insurance Financing and insurance if not addressed in a separate agreement. 
6.15 Publication Policy Publication policy, if not addressed in a separate agreement. 
6.16 Supplements (NOTE: Since the protocol and the clinical trial/study report are closely related, further relevant information can be found in the ICH Guideline for Structure and Content of Clinical Study Reports.) 

E4: Dose-Response Information to Support Drug Registration

E4: Dose-Response Information to Support Drug Registration

The tripartite harmonised ICH guideline was finalised (Step 4) in March 1994. This document gives recommendations on the design and conduct of studies to assess the relationship between doses, blood levels and clinical response throughout the clinical development of a new drug.

Cleaning Of Cooling Coil

1.0  Purpose     :       To provide a documented procedure for Cleaning of Cooling Coil.

                       

2.0   Objective  :       Cleaning of Cooling Coil.

       

3.0    Scope     :   This SOP is applicable for Cleaning of Cooling Coil.at ---Pharmaceuticals Ltd, .

4.0     Responsibility  :

·        Primary: Technician Engineering

·        Secondary: Manager Engineering

5.0    Procedure :

·        Remove main supply fuse & affix label to “DO NOT START, MACHINE UNDER CLEANING”.

·        Switch ‘OFF’ Air Handling Unit fan & chilled water valves.

·        Remove filters from Air Handling Unit.

·        Spray decaling chemical by pump on fins of cooling coil on both sides.

·        Clean cooling coil fins by water jet at 30 Ib/in² from both sides.

·        Check for satisfactory cleaning by looking through fins at light source at other side of coil.

Operation of Fire Extinguisher

1.0   Purpose    :       To provide a documented procedure for Operation of Fire Extinguisher.

                                                                                   

2.0   Objective  :       Operation of Fire Extinguisher

       

3.0  Scope  :   This SOP is applicable for Operation of Fire Extinguisher. at ----Pharmaceuticals   Ltd, 

4.0     Responsibility  :

·        Primary: Technician Engineering

·        Secondary: Manager Engineering

5.0    Procedure :

·        Foam Type Fire Extinguisher:

Ø      It should be used for fires involving solvents, oils, greases, fats, charcoals etc.

Ø      As these articles being lighter than water, will float on water and are likely to splash burning liquids on all sides.

·        CO₂ Gas Type Fire Extinguisher:

Ø       This type of extinguisher can also be used for fires involving inflammable liquids such as solvents, oils, greases etc.

Ø      The only difference between foam type and CO₂ type fire extinguishers must always be used in the event of an electrical fire.

·        Dry Chemical powder (DCP Type Extinguisher):

Ø       These are recommended mainly for tackling petroleum/solvents fires.

Ø         However they are suitable for gas fires

Cleaning of Filter of all AHU

1.0       Purpose     : To provide cleaning instruction of various types of filters in AHU as per safety and cGMP requirements.

2.0       Objective    :   To provide documented procedure for cleaning instruction of various types of filters in AHU as per safety and cGMP requirements

  3.0   Scope          :    This SOP covers the instructions for cleaning of pre-filters and fine filters of all AHU. The SOP specifies the responsibilities of staff for the various functions outlined here under.

4.0           Responsibility  :

·        Primary: Technician Engineering

·        Secondary: Manager Engineering

·         

5.0            Procedure :

• Ensure prior to clean:

Ø      Ensure that area connected to respective AHU is not in any use by its respective user department.

Ø      Intimate user department.

Ø      Stop the respective AHU and remove its fuses and put a board “EQUIPMENT IS UNDER MAINTENANCE” on the MCC feeder as well as on the AHU.

Ø      By pressing the local push button, ensure the respective AHU can not be started.

·        Cleaning Procedure for pre-filter and fine filter:

Ø      Remove the filters to be cleaned from the AHU by unscrewing all its bolts.

Ø      Number the filters with marker pen as per its original location so that they can be refixed on their same location.

Ø      Take all the filters to the filter cleaning room.

Ø      Wear rubber gloves and eye goggles.

Ø      Spray compressed air on the filter in the direction opposite to the air flow direction when the AHU is under working condition. Continue this process as per requirement of cleaning. Maintain air pressure in the range of 2 to 3 kg/cm2 g.

Ø      Then clean the filters with the help of tap water.

Ø      Then again spray compressed air on the filter in both the directions.  Continue this spray unless all the water is removed from the filter and filter is thoroughly clean.

Ø      Keep the cleaned filter on the rack for drying for 1 to 1.5 hrs.

Ø      Also clean all the section of AHU like return air section, supply air section, fan – motor section, cooling coil section and all the sides of AHU by cotton dipped in potable water and final drying using dry cotton waste.

Ø      Refix all the filters as per its number on their original position.

Ø      Also clean the filter cleaning room.

Ø      Insert the fuses of the AHU and ensure that there is no leakage by physical checking from any sides of the filters.

·        SAFETY, HEALTH AND ENVIRONMENTAL ASPECTS:

Ø      Before cleaning the filter:

R     Wear rubber gloves and eye goggles.

R     Remove the fuses of the respective AHU.

R     Put a board on the MCC feeder and AHU that “AHU IS UNDER MAINTENANCE.”