Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 4

Material Component Storage and Handling with respect to

• Are incoming material and components quarantined until approved for use? Check here YES / NO
• Are all materials handled in such a way to prevent contamination? Check here YES / NO
• Are all materials stored off the floor? Check here YES / NO
• Are materials spaced to allow for cleaning and inspection? Check here YES / NO
• Are labels for different products, strengths, dosage forms, etc., stored separately with suitable identification? Check here YES / NO
• Is label storage area limited to authorized personnel? Check here YES / NO
• Are rejected components, material, and containers quarantined and clearly marked to prevent their use? Check here YES / NO
  
  

Inventory Control Program for GMP

• Are inventory control procedures written? Check here YES / NO
• Does the program identify destruction dates for obsolete or out-dated materials, components, and packaging materials? Check here YES / NO
• Is stock rotated to ensure that the oldest approved product or material is used first? Check here YES / NO
• Is destruction of materials documented in a way that clearly identifies the material destroyed and the date on which destruction took place? Check here YES / NO

Vendor (Supplier) Control Program

• Are vendors periodically inspected according to a written procedure? Check here YES / NO
• Is the procedure for confirming vendor test results written and followed? Check here YES / NO

Operational Control

• Material/Component/Label Verification, Storage, and Handling Check here YES / NO
• Do written procedures identify storage time beyond which components, containers, and closures must be reexamined before use? Check here YES / NO
• Is release of retested material clearly identified for use? Check here YES / NO
• Are retesting information supplements originally obtained? Check here YES / NO
• Do written procedures identify steps in the dispensing of material for production? Check here YES / NO
• Do these procedures include (1) release by QC, (2)Documentation of correct weight or measure, and (3) Proper identification of containers? Check here YES / NO
• Does a second person observe weighing/measuring/dispensing and verify accuracy with a second signature? Check here YES / NO
• Is the addition of each component documented by the person adding the material during manufacturing? Check here YES / NO
• Does a second person observe each addition of material and document verification with a second signature? Check here YES / NO
• Does a written procedure specify who is authorized to issue labels? Check here YES / NO
• Does a written procedure specify how labels are issued, used, reconciled with production, returned when unused, and the specific steps for evaluation of any discrepancies? Check here YES / NO
• Do written procedures call for destruction of excess labeling on which lot or control numbers have been stamped or imprinted? Check here YES / NO

Reference : WHO guideline for GMP/Internet

Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 3

Equipment Identification with respect to GMP

• Are all pieces of equipment clearly identified with easily visible markings? Check here YES / NO
• Are all pieces of equipment also marked with an identification number that corresponds with an entry in an equipment log? Check here YES / NO
• Does each piece of equipment have written instructions for maintenance that includes a schedule for maintenance? Check here YES / NO
• Is the maintenance log for each piece of equipment kept on or near the equipment? Check here YES / NO

Equipment Maintenance & Cleaning with respect to GMP

• Are written procedures established for the cleaning and maintenance of equipment and utensils? Check here YES / NO
• Are these procedures followed? Check here YES / NO
• Does a written procedure assign responsibility for the cleaning and maintenance of equipment? Check here YES / NO
• Has a written schedule been established and is it followed for the maintenance and cleaning of equipment? Check here YES / NO
• Has the cleaning procedure been properly validated? with respect to who GMP guide for quality assurance .Check here YES / NO
• If appropriate, is the equipment sanitized using a procedure written for this task? Check here YES / NO
• Has a sufficiently detailed cleaning and maintenance procedure been written for each different piece of equipment to identify any necessary disassembly and reassembly required to provide cleaning and maintenance? Check here YES / NO
• Does the procedure specify the removal or obliteration of production batch information from each piece of equipment during its cleaning?
• Is equipment cleaned promptly after use? IS GMP FOLLOWED Check here YES / NO
• Is clean equipment clearly identified as "clean" with a cleaning date shown on the equipment? Check here YES / NO
• Is clean equipment adequately protected against contamination prior to use? Check here YES / NO
• Is equipment inspected immediately prior to use? Check here YES / NO
• Are written records maintained on equipment cleaning, sanitizing and maintenance on or near each piece of equipment? Check here YES / NO

Measurement Equipment Calibration Program for GMP

• Does the facility have approved written procedures for checking and calibration of each piece of measurement equipment? (Verify procedure and log for each piece of equipment and note exceptions in notebook with cross reference.) Check here YES / NO
• Are records of calibration checks and inspections maintained in a readily retrievable manner? Check here YES / NO

Equipment Qualification Program for GMP

• Verify that all pieces of equipment used in production, packaging, and quality assurance are capable of producing valid results. Check here YES / NO
• When computers are used to automate production or quality testing, have the computer and software been validated? Check here YES / NO
• Have on-site tests of successive production runs or tests been used to qualify equipment? Check here YES / NO
• Were tests repeated a sufficient number of times to ensure reliable results? Check here YES / NO
• Is each piece of equipment identified to its minimum and maximum capacities and minimum and maximum operating speeds for valid results? Check here YES / NO
• Have performance characteristics been identified for each piece of equipment? (May be provided by the manufacturer, but must be verified under typical operations conditions.) Check here YES / NO
• Have operating limits and tolerances for performance been established from performance characteristics? Check here YES / NO

Material/Component Specification and Purchasing Control

• Although purchasing is not specifically addressed in the current GMP regulation, incumbent upon user of components and materials to ensure quality of product, material or component. Check here YES / NO
• Has each supplier/vendor of material or component been inspected/audited for proper manufacturing controls? (Review suppliers and audits and enter names, material supplied, and date last audited in notebook.) Check here YES / NO
• Material/Component Receipt, Inspection, Sampling, and Laboratory Testing Check here YES / NO
• Does the facility have current written procedures for acceptance/rejections of drug products, containers, closures, labeling and packaging materials? (List selected materials and components in notebook and verify procedures.) Check here YES / NO
• Is each lot within each shipment of material or components assigned a distinctive code so material or component can be traced through manufacturing and distribution? Check here YES / NO
• Does inspection start with visual examination of each shipping container for appropriate labeling, signs of damage, or contamination? Check here YES / NO
• Is the number of representative samples taken from a container or lot based on statistical criteria and experience with each type of material or component?
• Is the sampling technique written and followed for each type of sample collected? Check here YES / NO
• Is the quantity of sample collected sufficient for analysis and reserve in case retesting or verification is required? Check here YES / NO
• Verify that the following steps are included in written procedures unless more specific procedures are followed:Containers are cleaned before samples are removed. Check here YES / NO
• Stratified samples are not composited for analysis. Check here YES / NO
• Containers from which samples have been taken are so marked indicating date and approximate amount taken. Check here YES / NO
• Each sample container is clearly identified by material or component name, lot number, date sample taken, name of person taking sample, and original container identification. Check here YES / NO
• At least one test is conducted to confirm the identity of a raw material (bulk chemical or pharmaceutical) when a Certificate of Analysis is provided by supplier and accepted by QA. Check here YES / NO

• If a Certificate of Analysis is not accepted for a lot of material, then additional testing is conducted by a written protocol to determine suitability for purpose. 
• Microbiological testing is conducted where appropriate. Check here YES / NO
  Reference : WHO guideline for GMP/Internet

Audit checklist for who GMP guideline compliance in pharmaceuticals_Part 2

Design Control with respect to who gmp,not directly related to the Drug Regulation

• Facility Control Check here YES / NO
• Facility Design and Layout Check here YES / NO
• Are all parts of the facility constructed in a way that makes them suitable for the manufacture, testing, and holding of drug products? Check here YES / NO
• Is there sufficient space in the facility for the type of work and typical volume of production? Check here YES / NO
• Does the layout and organization of the facility prevent contamination? Check here YES / NO

Environmental Control Program for GMP compliance

• The facility is NOT situated in a location that potentially subjects workers or product to particulate matter, fumes, or infestations? Check here YES / NO
• Are grounds free of standing water? Check here YES / NO
• Is lighting adequate in all areas? Check here YES / NO
• Is adequate ventilation provided? Check here YES / NO
• Is control of air pressure, dust, humidity and temperature adequate for the manufacture, processing, storage or testing of drug products? Check here YES / NO
• If air filters are used, is there a written procedure specifying the frequency of inspection and replacement? Check here YES / NO
• Are drains and routine cleaning procedures sufficient to prevent standing water inside the facility? Check here YES / NO
• Does the facility have separate air handling systems, if required, to prevent contamination? (MANDATORY IF PENICILLIN IS PRESENT!) Check here YES / NO

Facility Maintenance and Good Housekeeping Program for GMP

• Is this facility free from infestation by rodents, birds, insects and vermin? Check here YES / NO
• Does this facility have written procedures for the safe use of suitable, (e.g. those that are properly registered) rodenticides, insecticides, fungicides, and fumigating agents? Check here YES / NO
• Is this facility maintained in a clean and sanitary condition? Check here YES / NO
• Does this facility have written procedures that describe in sufficient detail the cleaning schedule, methods, equipment and material? with respect to who gmp guide for quality assuarance
• Does this facility have written procedures for the safe and correct use of cleaning and sanitizing agents? with respect to who gmp guide for quality assuarance, Check here YES / NO
• Are all parts of the facility maintained in a good state of repair ?
• Is sewage, trash and other refuse disposed of in a safe and sanitary manner (and with sufficient frequency?) Check here YES / NO

Outside Contractor Control Program

• Are contractors and temporary employees required to perform their work under sanitary conditions? with respect to who gmp guide for quality assuarance. Check here YES / NO
• Are contractors qualified by experience or training to perform tasks that may influence the production, packaging, or holding of drug products? Check here YES / NO

 Equipment Control with respect to who gmp

• Equipment Design and Placement Check here YES / NO
• Is all equipment used to manufacture, process or hold a drug product of appropriate design and size for its intended use? Check here YES / NO
• Are the following pieces of equipment suitable for their purpose? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the following pieces of equipment suitable in their size/capacity? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the following pieces of equipment suitable in their design? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the locations in the facility of the following pieces of equipment acceptable? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Are the following pieces of equipment properly installed? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify). Check here YES / NO
• Is there adequate space for the following pieces of equipment? Blender(s), Conveyor(s), Tablet, Presses, Capsule Fillers, Bottle Fillers, Other (specify),for GMP Check here YES / NO
• Are machine surfaces that contact materials or finished goods non-reactive, non-absorptive, and non-additive so as not to affect the product? Check here YES / NO
• Are design and operating precautions taken to ensure that lubricants or coolants or other operating substances do NOT come into contact with drug components or finished product? Check here YES / NO
• Fiber-releasing filters are NOT used in the production of injectable products? Check here YES / NO
• Asbestos filters are NOT used in the production of products, with respect to who gmp guide for quality assuarance? YES / NO
• Is each idle piece of equipment clearly marked "needs cleaning" or "cleaned; ready for service"? Check here YES / NO
• Is equipment cleaned promptly after use? YES / NO Check here YES / NO
• Is idle equipment stored in a designated area? Check here YES / NO
• Are written procedures available for each piece of equipment used in the manufacturing, processing or holding of components, in-process material or finished product? Check here YES / NO
• Do cleaning instructions include disassembly and drainage procedure, if required, to ensure that no cleaning solution or rinse remains in the equipment? Check here YES / NO
• Does the cleaning procedure or startup procedure ensure that the equipment is systematically and thoroughly cleaned? Check here YES / NO

Reference : WHO guideline for GMP/Internet

Audit checklist for who gmp guideline compliance in pharmaceuticals_Part 1

Dear all, here I provide a list of possible questions which an auditors are most likely going to ask and cheek for who gmp guideline compliance in pharmaceuticals inspection.

Before any inspection, hand over the copy of this to respective departments and make them ready for compliance of these questions.

Check pervious audit report , costumers feedback's , complaints etc and use this to verify the compliance for the particular point.

Following is the step by step guideline

With respect to requirements of who gmp guide for quality assuarance

• Does the pharmaceutical manufacturing firm ,organizational units ,operate in a state of control as defined by the GMP regulations? who gmp guidelines are followed? Check here YES / NO
• Organizational & Management Responsibilities for gmp. Check here YES / NO
• Does this facility/business unit operate under a facility or corporate quality policy? Check here YES / NO
• Does a Quality Assurance unit (department) exist as a separate organizational entity to ensuer all aspects of who gmp guide ? Check here YES / NO
• Does the Quality Assurance unit alone have both the authority and responsibility to approve or reject all components, drug product containers and closures, in-process materials, packaging materials, labeling and drug products? Check here YES / NO
• Does the QA department or unit routinely review production records to ensure that procedures were followed and properly documented with respect to GMP who gmp guide for quality assurance? Check here YES / NO
• Are adequate laboratory space, equipment, and qualified personnel available for required testing ? with respect to who gmp guide for quality assurance Check here YES / NO
• If any portion of testing is performed by a contractor, has the Quality Assurance unit inspected the contractor’s site and verified that the laboratory space, equipment, qualified personnel and procedures are adequate? Check here YES / NO
• Date of last inspection:____________________
• Are all QA procedures in writing? with respect to who gmp guidelines,who gmp guide for quality assuarance Check here YES / NO
• Are all QA responsibilities in writing? with respect to who gmp guide for quality assuarance Check here YES / NO
• Are all written QA procedures current and approved? (Review log of procedures) Check here YES / NO
• Are the procedures followed? (Examine records to ensure consistent record-keeping that adequately documents testing.)Check here YES / NO
• Are QA supervisory personnel qualified by way of training and experience with respect to who gmp guide for quality assuarance? Check here YES / NO
• Are other QA personnel, e.g., chemists, analysts, laboratory technicians) qualified by way of training and experience with respect to who gmp guide for quality assuarance? Check here YES / NO

Document Control Program

• Does the QA unit have a person or department specifically charged with the responsibility of designing, revising, and obtaining approval for production and testing procedures, forms, and records ,with respect to who gmp guide for quality assurance? Check here YES / NO
• Does a written SOP, which identifies how the form is to be completed and who signs and countersigns, exist for each record or form ,with respect to who gmp guide for quality assurance? Check here YES / NO
• Is the production batch record and release test results reviewed for accuracy and completeness before a batch/lot of finished product is released? Check here YES / NO

Employee Orientation, Quality Awareness, and Job Training with respect to gmp

• Circle the types of orientation provided to each new employee: (1) Company brochure (2) Literature describing GMP regulations and stressing importance of following instructions. (3) On-the-job training for each function to be performed (before the employee is allowed to perform such tasks). (4) Other: enter in notebook. Check here YES / NO
• Does each employee receive retraining on an SOP (procedures) if critical changes have been made in the procedure? Check here YES / NO
• Indicate how on-going, periodic GMP training is accomplished. Check here YES / NO
• Is all training documented in writing that indicates the date of the training, the type of training, and the signature of both the employee and the trainer? Check here YES / NO
• Are training records readily retrievable in a manner that enables one to determine what training an employee has received, which employees have been trained on a particular procedure, or have attended a particular training program? Check here YES / NO
• Are GMP trainers qualified through experience and training Check here YES / NO
• Are supervisory personnel instructed to prohibit any employee who, because of any physical condition (as determined by medical examination or supervisory observation) that may adversely affect the safety or quality of drug products, from coming into direct contact with any drug component or immediate containers for finished product? Check here YES / NO
• Are employees required to report to supervisory personnel any health or physical condition that may have an adverse effect on drug product safety and purity? Check here YES / NO
• Are temporary employees given the same orientation as permanent employees?
• Are consultants, who are hired to advise on any aspect of manufacture, processing, packing or holding, of approval for release of drug products, asked to provide evidence of their education, training, and experience? Check here YES / NO
• Are written records maintained stating the name, address, qualifications, and date of service for any consultants and the type of service they provide? Check here YES / NO

Plant Safety and Security

• Does this facility have a facility or corporate safety program? Check here YES / NO
• Are safety procedures written? Check here YES / NO
• Are safety procedures current? Check here YES / NO
• Do employees receive safety orientation before working in the plant area? Check here YES / NO
• Is safety training documented in a readily retrievable manner that states the name Check here YES / NO
• of the employee, the type of training, the date of the training, and the name of the trainer and the signature of the trainer and the participant? Check here YES / NO
• Does this facility have a formal, written security policy? Check here YES / NO
• Is access to the facility restricted? Check here YES / NO
• Describe how entry is monitored/restricted: Check here YES / NO
• Is a security person available 24 hours per day? Check here YES / NO
  
  

Internal Quality/who gmp Audit Program

• Does this business unit/facility have a written quality policy? Check here YES / NO
• Is a copy of this quality policy furnished to all employees? Check here YES / NO
• If "yes" to above, when provided? __________________
• Is training provided in quality improvement? Check here YES / NO
• Does a formal auditing function exist in the Quality Assurance department? Check here YES / NO
• Does a written SOP specify who shall conduct audits and qualifications (education, training, and experience) for those who conduct audits? Check here YES / NO
• Does a written SOP specify the scope and frequency of audits and how such audits are to be documented? Check here YES / NO
• Does a written SOP specify the distribution of the audit report? Check here YES / NO

Quality Cost Program for gmp cgmp

• Does this facility have a periodic and formal review of the cost of quality? Check here YES / NO
• Does this facility have the ability, through personnel, software, and accounting Check here YES / NO
• Records, to identify and capture quality costs? Check here YES / NO
• Does this facility make a conscious effort to reduce quality costs? Check here YES / NO

Reference: WHO guideline for GMP/Internet

Guideline handling of loose containers of raw materials

1.0 After dispensing of material,container & inner polybag of the loose material to be closed properly.
1.1 Weigh the loose container and record the Gross weight on the label.
1.2 Based on the original tare weight calculate the net weight of the loose material and record the net weight on the label as per annexure attached.
1.3 Sign the label and affix the loose container label on the container over the earlier loose container label after verifying the details.
1.4 Before affixing the loose container label strike off the earlier loose container label.
1.5 Send back the loose container to warehouse through the material exit box after dedusting and cleaning
1.6 The same loose container to be taken first for next dispensing

Guideline for sterility test procedure of eye drops

Preparation of media: (Thioglycollate & Sabouraud Dextrose)

Prepare as directed in the label of the manufacturer. Transfer 15-20 ml to each 50 ml flat bottom flask (about 10 flask taken) and introduce a cotton plug to each, wrapping with paper and fasten the neck with thread. Sterilize in an autoclave at 121⁰c/15 lb pressure for 20 minutes. After autoclaving place them in front of LAFB. After achieving the room temperature, incubate for 24-48 hours and then store for use if no evidence of contamination is found.

Filtration Method (Pore Size 0.2 µm): Prepare each membrane filter as follows. Transfer a small quantity (sufficient to moisten the membrane filter) of sterile diluent of 0.1% w/v neutral solution of meat peptone. Sample taken 2 ml in 100 ml sterile 0.1% w/v neutral solution and filter through the membrane filter and further pass through the membrane filter about 150 ml sterile diluent in such a manner that the effect of the antibiotic is neutralized in a greater magnitude. The filtration apparatus and membrane are sterilized by appropriate means. The preparation being tested is transferred through a membrane filter paper. The membrane is washed at least three times by filtering through it each time with the sterile dilute isopropyl myristate.

The membrane is cut aseptically into two equal parts and transfer one half to each of the media i.e. Thioglycollate  broth & Sabouraud dextrose broth. (also perform a control test without the sample). Incubate at 30-35⁰c for bacteria (or 20-25⁰c for fungi) for 7 days. Observe the culture media several times during the incubation period. At intervals during the incubation period and its conclusion, examine the media for microscopic evidence of microbial growth.

When the material being tested render the media turbid so that the presence or absence of microbial growth can not be determined readily by visual examination 7 days after the incubation started, transfer suitable portions of the cultured media to fresh vessel of the same medium. Continue incubation of the original and transferred vessel for a total 14+7 = 21 days from the original incubation. If no evidence of microbial growth is found, the product being examined complies with the test for sterility.  If evidence of microbial growth is found  (turbid solution), the product being examined does not comply with the test for sterility.

PRECAUTION:

               I.      Before entering the working room wash the hands and mouth and dry in fresh air.

             II.      Swab the hands with sterile 70% isopropyl alcohol and put on mask & sterile hand gloves.

            III.      During working infront of LAFB, the UV light must be off.

Guideline for sterility test procedure of ointment

Preparation of media: (Thioglycollate & Sabouraud Dextrose)

Prepare as directed in the label of the manufacturer. Transfer 15-20 ml to each 50 ml flat bottom flask (about 10 flask taken) and introduce a cotton plug to each, wrapping with paper and fasten the neck with thread. Sterilize in an autoclave at 121⁰c/15 lb pressure for 20 minutes. After autoclaving place them in front of LAFB. After achieving the room temperature, incubate for 24-48 hours and then store for use if no evidence of contamination is found.

Filtration Method (Pore Size 0.2 µm): This method is used for checking the sterility for eye ointment; 10 ointment tubes are sampled randomly. Not less than 2.5 g ointment are taken in sterile isopropyl myristate and diluted in such a manner that the effect of the antibiotic is neutralized in a greater magnitude. The filtration apparatus and membrane are sterilized by appropriate means. The preparation being tested is transferred through a membrane filter paper. The membrane is washed at least three times by filtering through it each time with the sterile dilute isopropyl myristate.

The membrane is cut aseptically into two equal parts and transfer one half to each of the media i.e. Thioglycollate  broth & Sabouraud dextrose broth. (also perform a control test without the sample). Incubate at 30-35⁰c for bacteria (or 20-25⁰c for fungi) for 7 days. Observe the culture media several times during the incubation period. At intervals during the incubation period and its conclusion, examine the media for microscopic evidence of microbial growth.

When the material being tested render the media turbid so that the presence or absence of microbial growth can not be determined readily by visual examination 7 days after the incubation started, transfer suitable portions of the cultured media to fresh vessel of the same medium. Continue incubation of the original and transferred vessel for a total 14+7 = 21 days from the original incubation. If no evidence of microbial growth is found, the product being examined complies with the test for sterility.  If evidence of microbial growth is found  (turbid solution), the product being examined does not comply with the test for sterility.

PRECAUTION:

               I.      Before entering the working room wash the hands and mouth and dry in fresh air.

             II.      Swab the hands with sterile 70% isopropyl alcohol and put on mask & sterile hand gloves.

            III.      During working infront of LAFB, the UV light must be off.

Guideline for regeneration of cation exchanger , anion exchanger and mixed bed

A) For Cation Bed
Make a regenerant solution ready by pouring 120 lit. of HCl into 100 Lt. of water.
REGENERANT QUANTITY : 120 ltrs. of 30% concentration commercial grade Hcl ) DILUTION WATER QUANTITY : 100 ltrs. of water
INJECTION TIME : 30 minutes
RINSING TIME : 10 minutes
B) For Anion Bed
Make the regenerant solution ready as per the quantities given below
REGENERANT QUANTITY : 18 kgs of NaoH (rayon grade)
DILUTION WATER QUANTITY : 150 ltrs of cation water
INJECTION TIME : 30 minutes.
RINSING TIME : 30 minutes.
C) For Mixed Bed
Make the regenerant solution ready as per the quantities given below.
REGENERANT QUANTITIES : 7.5 kg. of HCLcommercial grade (30% concentration) and 2.5 kg of NaoH (rayon grade).
DILUTION WATER QUANTITIES : 12 lts. of DM water for dilution of Hcl and 25 lts.of DM water for dilution of NaoH.
BACK WASH TIME : 10 minutes.
INJECTION TIME : 15 minutes (for HCL).
INJECTION TIME : 15 minutes (for NaoH).
RINSING TIME : 10 minutes (for both cation and anion).
AIR MIXING TIME : 15 minutes (0.5 kg/cm2 pressure).
FINAL RINSING TIME : 30 minutes.

OPERATION
1.0 For Cation Bed
1.1 While preparing a solution pour 120 Ltrs HCL into 100 Ltrs of water.
1.2 Open the valves CBV-6 & CBV-5 fully (CBV-1, CBV-2 and CBV-3 should be closed).
1.3 Open the valve CBV-4 such that the prepared solution is injected into the exchanger in 30 Minutes.
1.4 As soon as injection is over close CBV-5 and open CBV-4 fully so that the HCL solution remaining in the pipe line will be flushed out for 1 minute.
1.5 Close CBV-4 and CBV-6.
1.6 Open the CBV-1 and CBV-3 fully for 10 minutes (or)till pH comes to 2.5 to 3.5 with the help of pen type PHmeter.
1.7 As soon as pH comes within the range close CBV-3 and open CBV-2.

For Anion Beds
2.1 Open the valves ABV-6 and ABV-5 fully (ABV-1, ABV-2, ABV-3 should be closed.)
2.2 Open the valve ABV-4 such that the prepared solution is injected into the exchange in 30 minutes.
2.3 As soon as injection is over close ABV-5 and open ABV-4 fully so that the NaoH solution remaining in the pipe line will be flushed out for one minute.
2.4 Close ABV-4 and ABV-6.
2.5 Open ABV-1 and ABV-3 rinse it for 30 minutes (or) till conductivity comes to less than 20 ms /cm (or) till PH comes 8 to 10 with the help of pen type PH meter.
2.6 As soon as the conductivity comes to less than 10 ms/cm close ABV-3 and open ABV-2.
For Mixed Bed
3.1 Back Wash : Open MBV-3 partially and open MBV-4 fully so that the cation and anion resin beds remain separated (See through sight glass).
3.2 Soda Injection
a) Open the MBV-6 and MBV-7 fully.
b) Open the MBV-5 such that the prepared solution is injected into the bed within 15 minutes.
c) As soon as injection is over close MBV-6 and open MBV-5 fully and allow the NaoH solution in the pipe line to drain for 1minute and then close MBV-5.
3.3 Soda Rinse : Open MBV-1 and MBV-7 to rinse the anion resin for 10 minutes and close MBV-1 and MBV-7.
3.4 Acid Injection:
a) Open MBV-9 and MBV-10 fully.
b) Open MBV-8 such that the prepared solution is injected with in 15 minutes.
c) As soon as the injection is over close MBV-9 and open MBV-8 fully allow the HCL solution to drain for 1 minute after 1 minute close the MBV-8.
3.5 Acid Rinse: Open MBV-11 and MBV-10 and allow rinsing for 10 minutes and closing MBV- 10 and MBV-11.
3.6 Air Mixing : Open MBV-12 and MBV-4, the air pressure should be 0.5 Kg/sq.cm. for 15 minutes, see that proper mixing should takes place and close MBV-12 and MBV-4.
SHUT DOWN
Final Rinsing : Open MBV-1 and MBV-10 and allow the water to drain for 30minutes (or) while the conductivity comes below 01ms/cm (or) till PH comes 6-7 with the help of pen type PH meter, then close MBV-10 and open MBV-2 collect the water in the storage tank.

Abbrevations:
MBV - Mixed Bed Valves
ABV - Anion Bed Valves

SOP for Receipt of On-line Rejected Materials

1.0 OBJECTIVE
To lay down a procedure for Receipt of “On-line Rejected Materials”.
2.0 SCOPE
Production, Packing hold area and dispensing area.
3.0 RESPONSIBILITY
Officer- Production / Officer - Warehouse
4.0 ACCOUNTABILITY
Assistant Manager - Production and Asst.Manager -Warehouse.
5.0 PROCEDURE
5.1 On-line rejected materials to be received with On-line rejection note duly signed by the Assistant Manager - Production./Quality Assurance.
5.2 On-line rejected material to be labelled as “On-line rejects”.
5.3 On-line rejected labels are to be signed by the Officer Production /Officer - Quality Assurance Department.
5.4 Stock return note to be raised by the Officer - Production for returning the On-line rejects and counter signed by Quality Assurance.
5.5 The stock return note to contain the S.No. and Date of On line Rejection with reasons.
5.6 The On-line rejected material to be sent to Dispensing room properly labelled along with a Online rejection note.
5.7 The On-line rejected material to be weighed inside the Dispensing room by Officer - Warehouse in presence of Officer - Production.
5.8 The stock return note to be signed by Officer - Warehouse and countersigned by the Officer - Production.
5.9 The On-line rejected material to be taken to Raw-material/Packing material Warehouse through the pass box and stored in rejected area.
5.10 On line rejections should be informed to Purchase Department with in a week for their further action.
5.11 Post the online rejected quantities with details in SAP.