ICHAPPS

OPTICAL ROTATION: Substances that may show optical rotatory power are chiral. Those that rotate light in a clockwise direction as viewed towards the light source are dextrorotatory, or (+) optical isomers. Those that rotate light in the opposite direction are called levorotatory or (–) optical isomers. SPECIFIC ROTATION : The specific rotation of a chemical compound [α] is defined as the observed angle of optical rotation α, when plane-polarized light is passed through a sample with a path length of 1 decimeter and a sample concentration of 1 gram per 1 deciliter. The specific rotation of a pure material is an intrinsic property of that material at a given wavelength and temperature. General Testing Procedure , OPTICAL , ROTATION

The ash content of a drug is the inorganic residue remaining after incineration, which is converted to the sulphated form. The substance is ignited with concentrated sulphuric acid which decomposes and oxidises organic matter, leaving a residue of inorganic sulphates.   RESIDUE , IGNITION , General Testing Procedure , sulphated

gnite the silica, platinum, porcelain or quartz crucible at 600°C ± 50°C for about 30 minutes. Allow to cool in a desiccator for about 30mins (Silica gel or other suitable desiccants) and weight (W1 g). Transfer accurately about 1 to 2 g of the sample or the amount specified in the individual Standard testing procedure into the crucible. Take the weight accurately (W2 g). (3) Moisten the substance with a small amount (usually 1mL) of sulphuric acid and heat  gently at low temperature as practical until the sample is thoroughly charred.  Cool and moisten the residue with a small amount (usually 1mL) of sulphuric acid. (4)Heat gently until white fumes no longer are evolved, and ignite at 600 ± 50 °C, in a muffle furnace unless temperature is specified in the individual monograph, until the carbon is consumed. Ensure that the flames are not produced at any time during the analysis. General Testing Procedure , SULPHATED ASH , carbon, platinum

Total combined molds and yeasts count is one type of fungal purity testing, which is used to count the number of colony forming unit present in an article complying with monograph standards. Sodium hydroxide 1N: Dissolve 4.0 g of sodium hydroxide in water to make 100 mL. Hydrochloric Acid 1N: Dissolve 8.5 ml of Hydrochloric Acid in water to make 100 mL. General Testing Procedure , COMBINED MOLDS, YEASTS COUNT

Escherichia coli are one of many species of bacteria living in the lower intestines of mammals, known as gut flora. When located in the large intestine, it assists with waste processing, vitamin K production, and food absorption. It was discovered in 1885 by Theodor Escherich, a German pediatrician and bacteriologist.   H owever, the bacteria are not confined to this environment, and specimens have also been located, for example, on the edge of hot springs. The E . coli strain O157:H 7 is one of hundreds of strains of the bacterium that causes illness in humans. General Testing Procedure 

Salmonella is a Gram-negative, motile bacterium. It was named after Daniel Elmer Salmon, an American veterinary pathologist, although it was his partner and contemporary Theobald Smith (better known for his work on anaphylaxis)who first discovered the bacterium in 1885 from pigs. Salmonella is a genus of rod-shaped Gram-negative enterobacteria that auses typhoid fever, paratyphoid fever, and food borne illness. Salmonella species are motile and produce hydrogen sulfide. SALMONELLA , General Testing Procedure

To provide a procedure to operate and maintain the Shimadzu make Class VP series Gradient HPLC system. This procedure is applicable for the GRADIENT HPLC, Shimadzu -Class VP series used in the Quality Control department. RESPONSIBILITY : It is the responsibility of all the personnel involved in the analysis using of the  Operation , Calibration, Shimadzu, GRADIENT

Description pertaining to an article, which is relatively general in nature is solely to indicate properties of an article complying with monograph standards. The properties are not in themselves standards or tests for purity even though they may indirectly assist in preliminary evaluation of an article.  APPEARANCE , crystalline nature, embossing, evaporating dish

The test determines the amount of volatile matter of any kind (including water) that can be driven off under the conditions specified. The test is carried out on a well mixed sample of the substance. If the substance is in the form of large crystals, reduce the size to about 2 mm by rapid crushing to a powder. LOSS ON DRYING , large crystals, accurately weigh , suitable desiccator

This test is provided to demonstrate that the content of metallic impurities that are colored by sulfide ion, under the specified test conditions, does not exceed the heavy metals limit specified in the individual monograph in terms of the percentage (by weight) of lead in the test substance, as determined by concomitant visual comparison. HEAVY METALS , Hydrochloric, Thioacetamide

Dimensions instrument : Vernier Calipers. Clean the tablets with a small and soft nylon brush. calipers and measure the diameter in mm. Similarly measure the diameter of not less than 6 tablets and calculate the average. 2. THICKNESS Instrument: Vernier Calipers. Clean the tablets with a small and soft nylon brush. Place the tablets vertically in-between the two jaws of the vernier calipers and measure the thickness in mm. Similarly measure the thickness of not less than 6 tablets and calculate the average. DIMENSIONS , Vernier Calipers, soft nylon brush

Spectrophotometric tests are commonly used in the Identification of chemical substances and quantification of polymorphic forms. The test procedures are applicable to substances that absorb IR radiation. The IR absorption spectrum of a substance compared with that obtained concomitantly for the corresponding reference standard / reference substance provide conclusive evidence of the identity of the substance being tested. Spectrophotometric , potassium chloride, evaporate

Operate the KF titrator using suitable operating procedure. A commercially available, stabilized solution of Karl Fischer type reagent may be used. Commercially available reagents containing solvents or bases other than pyridine or alcohols other than methanol may be used also. The diluted Reagent called for in some monographs should be diluted as directed by the individual testing procedure. Either methanol or other suitable solvent, such as ethylene glycol monomethyl ether, may be used as the diluent. The same solution shall be standardized. Standardization of KF Reagent by Water : Unless otherwise specified, transfer 35 to 40 mL of methanol or other suitable solvent to the titration vessel. Neutralise the solvent with KF reagen t. Weigh accurately between 25 to 250mg of water, transfer it into the titration vessel. Titer the content with Karl Fischer reagent to end point to the electrometric or visual endpoint. Perform the above titration in duplicate. Calculate the Factor u...

Pseudomonas aeruginosa is a Gram-negative, aerobic, rod-shaped bacterium with unipolar motility. An opportunistic human pathogen, P. aeruginosa is also an opportunistic pathogen of plants. It secretes a variety of pigments, including pyocyanin (blue-green), fluorescein (yellow-green and fluorescent, now also known as pyoverdin), and pyorubin (red-brown). It is oftenpreliminarily identified by its pearle scent appearance and grape-like odor in vitro. Definitive clinical identification of P. aeruginosa often includes identifying the production of pyocyanin and fluorescein as well as its ability to grow at 42°C. It is capable of growth in diesel and jet fuel, where it is known as a hydrocarbon utilizing microorganism (or "HUM bug"), causing microbial corrosion. It creates dark gellish mats sometimes improperly called "algae" because of their appearance. General Testing Procedure , PSEUDOMONAS, opportunistic pathogen

Specific gravity is based on the ratio of the ‘weight of the substance in air at 25°C to that of an equal volume of water at the same temperature. Unless otherwise stated in the individual testing procedure, the specific gravity determination is applicable only to liquids. SPECIFIC GRAVITY , General Testing Procedure, temperature, testing procedure

Food shall be brought in closed containers by identified Human Resource personnel till the entrance gate of sensitive product blocks. Dedicated Canteen personnel of sensitive product blocks shall carry the closed food containers from the entry gate to the canteen within the sensitive product block facility. Food utensils shall be washed and cleaned within the canteen facility and shall be taken to the entry gate by the dedicated sensitive product block housekeeping personnel. Provision of Food , canteen facility

Cobaltous chloride CS (Red solution) (Mol. Formula: CoCl2.6H2O, Mol. Wt: 237.93) Reagents: Hydrogen peroxide TS: Pipette 10 mL of 30% hydrogen peroxide solution into a 100 mL volumetricflask, dilute to volume with purified water. Sodium hydroxide solution (1 in 5) : Mix 10 g of sodium hydroxide with 50 mL of purified water. Dilute sulfuric acid (1 in 4) : Mix 10 mL of sulfuric acid with 40 mL of purified water. General Testing Procedure, COLORIMETRIC SOLUTIONS , Standardization

Entry procedure for Visitor (s ), Vendor (s), Customer (s), Government Official (s), Auditor (s), Contractor (s), Service Engineer (s) or any other personnel other than employees shall considered as Visitor(s). All Visitor (s) shall enter into the factory through main gate. Security shall take authorization to allow the visitor (s) from the concerned officials. Visitor (s) should not carry any objectionable items such as Smoking material, Match Boxes, Gutkha, Tobacco or any toxic materials. Visitors Entry , Exit, VISITORS REGISTER

Assistant – Human Resource shall maintain personal file for each employees The following documents shall be kept in the personal file Joining Report Medical Records in a sequential manner Personnel File , employees, Medical Records

Any Incident / Near Miss / Accident shall be reported to the Department head or his designee In case of major causality, the same shall be informed to Human Resource department. First aid shall be given by the trained personnel, if required. Human Resource Department shall accompany the injured person (s) to the nearer hospital in the provided ambulance. Treatment shall be given as per the respective doctors advice. Accident , Injured, medical fitness certificate, doctors

First Aid boxes with Band-aids, bandages, scissors, Antiseptic wipes and ointments, tablets (painkillers cold, motions and fever) shall be provided in the departments. Human Resource shall train selected personnel in each department on the usage of first aid boxes and the trained personnel names shall be kept at the security and the list shall be periodically updated. First Aid shall be given to employee (s) as and when required by the trained personnel. Medicines in the first aid box shall be monitored once in a month or as and when required. Band-aids , scissors, Antiseptic wipes, monitored

PROCEDURE : Human Resource shall maintain the linen room. The uniforms shall be stitched according to department requirements. All dresses in respective departments shall be arranged neatly. Every Monday and Thursday the fresh uniforms shall be issued to respective department employees and records shall be maintained as per the format Issue of the garments to employees. Human Resource department will arrange to get the soiled uniforms washed and laundered by the laundry person at the frequency of twice in a week. Colour coding : Executive working in all production areas – White Aprons Employees working in all production areas except C, D, and E blocks – Grey colour Aprons Employees working in C, D, and E blocks and powder processing areas of A, B and warehouse dispensing – Light green colour boiler suit with hood and booties. Executives working in Maintenance department – Dark blue Colour aprons Employees working in Maintenance department – Dark blue Dungarees. Employees working in ...

Switch off the power supply of Pesto-flash. Wear disposable hand gloves. Remove the bottom tray and collect the insects, if any into a polythene bag. Open the front metal frame. Lift the frame up and carefully clean the inside grill without disturbing the electrical bulbs and collect the waste into the polythene bag. Carefully clean the bulbs with a dry cloth Clean the inside grills with a dry cloth. Clean the metal frame with a dry cloth Pesto Flash , dry cloth, polythene bag

Scrap essentially consists of metal scrap (MS, SS, Aluminum etc.) arising from engineering fabrication work and fiber drums, HDPE drums, carboys and polythene covers etc. from raw material packaging.Collection of Scrap: Scrap collection points are identified at the following locations. Scrap arising are placed in the above collection points. Scrap from these points are periodically shifted to scrap disposal yard outside Scrap segregation is done at disposal yard – namely as MS, SS, Aluminum, HDPE drums, carboys, fiber drums, polyethylene bags and cardboard cartons. Scrap is disposed from the disposal yard. Collection , Transfer, Disposal of Scrap, segregation

In thin-layer chromatography, the adsorbent is a relatively thin, uniform layer of dry, finely powdered material applied to a glass, plastic, or metal sheet or plate, glass plates and aluminum plates being most commonly employed. The separation achieved may be based upon adsorption, partition, or a combination of both effects, depending on the particular type of stationary phase, its preparation, and its use with different solvents.   General Testing Procedure, Procedure, chromatography , thin layer chromatography

PROCEDURE International auditor (s) are treated as visitor (s) on any of the manufacturing sites. The proposing department shall raise a requisition for the activities of the visit and seek approval of Senior Management. No visitor (s) is permitted to visit the operating sites without approval of Senior Management. The audit proposal letter or an agenda is required for visitor (s)/auditor (s) to visit any of the manufacturing sites. The proposing department in conjunction with the visitor (s)/auditor (s) shall plan the visit/audit. The plan essentially consist of Purpose of visit. Schedule of visit Proposed / tentative agenda Name (s) of the visitor (s)/ auditor (s) The plan of visit/audit is informed to concerned site coordinator by the proposing department. The proposing department shall assign a coordinator for the visit. The primary responsibilities of the coordinator include the following but not limited to Based on travel schedule make arrangements for accommodation, tra...

Entry procedure of Employee(s) All employee (s) shall enter into the factory through security main gate only. Employee (s) should not carry any objectionable items such as Smoking material, Match Boxes, Gutkha, Tobacco or any toxic materials. Security shall inspect each employee for the presence of any objectionable items. Security shall dispose the objectionable items, if any. Employee (s) shall register the entry time by Thumb Impression (BIO MATRIX READER) / registering the time at the security. Every one shall keep his personal belongings in their individual lockers under lock and key. As the use of mobile phones are prohibited inside the plant premises all employees should handover their mobile phones to the security officer for safekeeping. Employee (s) shall follow Entry and Gowning procedures of the respective working area. Exit procedure for Employees Employees shall follow Exit procedures of the respective working area. Take out the personnel belongings, if any from the r...

PROCEDURE All new employees shall be subjected to complete medical checkup as per format no. xxxxx Employees working in the cephalosporin manufacturing area shall be tested for cephalosporin resistance. The employees who have cephalosporin resistance only shall be allowed to work in those areas. Occupational exposure (i.e. Chemical Exposure, Noise Exposure etc.,) & Health Effects shall be conducted and data shall be generated during periodical medical examination . Audiometric Test shall be conducted for the employees who are working in D.G. & Boiler Operations during pre-employment and periodical medical examinations. Medical checkup shall be conducted for all employees once in a year as per format no. xxxxx If any employee is found medically unfit, the employee is not allowed to work till he attains medical fitness. Administration , Procedure, Medical Checkup

PROCEDURE Procedure for Outward Material Entries As soon as the material accompanied by the returnable gate pass reach the security office the A.S.O. on duty shall check ensure the consignment as per documents as follows- Description of the material Quantity of the material Whether the consignment signed by the authorised person. Security shall inspect the consignment and ensure only the material pertaining to the document received is present. In case of any discrepancy security shall contact Human Resource dept. and Warehouse to resolve the issue. Upon resolving the issue security shall make outward entries as per formatxxxxx. In charge security shall stamp the outward documents as per format xxxxx Security in-charge shall instruct the guard to allow the material out. Procedure for Inward Material Entries On receipt of the material which has gone on returnable gate pass the documents shall be sent to concerned warehouse, on confirmation from warehouse the security shall check the...

Personal Hygiene Practices Medically fit employees are allowed to work in processing areas. Employees suffering from any illness / contagious diseases like viral fever, sever cold, conjunctivities etc. should report to their concerned Department Head / shift in-charge. Employees suffering from above diseases shall not be allowed to work in processing areas. Personal Hygiene Code of Conduct Employee shall be in good health. Employees shall have short hair and clean shave. Employee shall keep nails cut. Ornaments shall not be allowed in the process area. Eatable items shall not be allowed in the process area Consumption of Alcohol, Chewing, smoking, Gutkha is prohibited in the premises. Gowning procedure shall be followed as per gowning procedure. Protective gowning for handling the hazardous and toxic chemicals shall be as per defined area procedure Administration, Personal, Hygiene 

Separate overhead storage tank is kept on the top of the canteen and water will be distributed to various areas in the canteen. Water in the canteen and toilets will be distributed at necessary areas through pipes and will be operated with taps. Every day assistant from HR dept will monitor the canteen and toilets and observes the water usage in the canteen and toilets. If any leakage is found it will be repaired in coordination with the maintenance dept personnel. Sufficient vessels like buckets etc. are used for cleaning the canteen hall, toilets and other areas. Canteen and toilets floors are cleaned with the help of rubber and woollen wipers. Canteen and toilets will be cleaned thrice a day or whenever necessary under the supervision of HR dept. Canteen , Toilets , cleaning

Canteen utensils shall be cleaned at the designated place in the canteen. The garbage shall be collected in bins from the different places of the canteen. Collected garbage in bins shall be taken out of the security gate by trolleys under supervision of the canteen supervisor. The garbage shall be disposed out side the factory at the designated place, in land fills specially made for this purpose and covered with Mud/Soil. Garbage, Canteen, designated

As soon as a Raw / Packing material consignment arrives at the factory gate, security personnel shall confirm that the material Security shall confirm the place of delivery from the concerned warehouse. Security shall send the documents to the concerned warehouse. Upon receipt of the documents warehouse shall check and ensure the following: Material is for Purchase order exists for the supply. Whether the vendor is approved vendor or not. Certificate of Analysis is enclosed. Invoice / Delivery challan is enclosed. Packing list, if any Lorry Receipt, if any Relevant Excise documents, if any In case of any discrepancy, warehouse shall contact purchase department to resolve the issue. Upon resolving the issue, warehouse shall instruct the security department to allow the material to allow the material inside. Security shall enter the details in the concerned area material inward register as per format no.  xxxxx Security shall put an inward stamp on the back side of the Invoice /...

Organogram of department / blocks shall be prepared by respective Incharge in the format noxxxxx All departments organogram shall be approved by GM- Operation or designee, except Quality unit. Quality Unit operations of independent of production and fulfills both quality assurance (QA) and quality control (QC) responsibilities. The quality unit is in the form of separate QA and QC units. Employee profile and job responsibilities of all personnel should be specified in writing as per format no. xxxxx Head of the concerned department shall define the job responsibilities of the personnel and explain the same to the personnel working in the department. Acceptance shall be taken from the concerned personnel for the allotted responsibility and shall be approved by concerned Head of the department. VP- Operations / Designee shall approve employee profile and Job responsibilities of the heads of the Quality Assurance and Plant Incharge.Plant head shall approve employee profile and Jo...

As soon as soon as the material accompanied by the outward gate pass and / or Invoice reach the security office, security personnel on duty shall check and ensure consignment is as per the documents as follows. The name of the material. The number of containers, Whether the consignment is authorized by the authorized persons. Security shall inspect the vehicle and ensure only the material pertaining to the documents received is present in the vehicle. In case of any discrepancy, security shall contact Human Resource department and warehouse to resolve the issue. Upon resolving the issue, security shall make outward entries as per format no. xxxxx. Security shall stamp the outward documents as per format no. xxxxx. In- charge security shall then instruct the respective security guard to allow the material out. Administration, Procedure, security checks

Employee competency shall be prepared by Executive- HR in co-ordination with respective department heads in the format xxxxx. Competence shall be prepared based on the following requirements, but not limited to Personnel performing work affecting conformity to product requirements. General requirements such as communication skills, adaptability skills etc., Any other specifically required by the Head of respective departments. The Employee competency shall have the following requirement details, but not limited to Designation Department Qualification Experience Core competencies General competencies : The Employee competency shall be reviewed / revised as and when required. Employee , Designation, Department, Qualification

Operating Procedure : Bulk inward and outward materials like solvents, coal and scrap etc. shall be weighed using the weighbridge located opposite to the existing gate of the site. Concerned warehouse person should be present while weighing the vehicle for cross checking the weights. During the entry to the plant the gross weight shall be recorded and during exit the tare weight shall be recorded to get the net weight. If the empty vehicle is arrived for loading first tare weight will be recorded, and the loaded vehicle will be weighed again to obtain the gross weight that will be recorded to get the net weight. Weighment entries shall be issued to the warehouse section by Human Resource. Details of vehicles and their corresponding gross, tare and net weights along with the vehicle number and name of the item shall be recorded in a register maintained for the purpose.Procedure for Maintenance of Weigh Bridge : The weighbridge shall undergo an annual certification procedure by the O...

All the employees working in cephalosporins blocks will be picked up from their pickup points by a separate company bus identified  by its registration number and brought to the factory. Bus with employees of these blocks will reach cephalosporins blocks security gate via the main factory gate. The security officer at cephalosporins blocks gate will be operating for the entry and exit of the bus. All the cephalosporins blocks employees have to follow entry procedure as per sop no. xxxxx. All the employee of cephalosporins blocks should board the dedicated bus and leave the factory from the cephalosporins block . gate.Separate entry and exit records shall be maintained for cephalosporins blocks as per sop no. xxxxx Procedure, Manufacturing , Administration

Methylcobalmin - 1500 mcg Model of pack:2ml Packing:Ampl Methylcobalmin - 1500 mcg , VITABALMIN-1500 AMPOULES

Amicacin - 100 mg Model of pack:2ml Packing:Vial Amicacin - 100 mg , AMICOTAL - 100 VIALS

Amicacin - 250 mg Model of pack:2ml Packing:Vial Amicacin - 250 mg , AMICOTAL - 250 VIALS

Pantoprazole - 40mg  Model of pack:40ml Packing:Vial Pantoprazole - 40mg , PANOTAL VIALS

Amicacin - 500 mg Model of pack:2ml Packing:Vial Amicacin - 500 mg , AMICOTAL - 500 VIALS

Ceftriaxone - 250mg Model of pack:250 mg Packing:Vial Ceftriaxone - 250mg , TRICOCEF - 250 VIALS

Ceftriaxone - 1000mg Model of pack:1000 mg Packing:Vial Ceftriaxone - 1000mg , TRICOCEF - 1000 VIALS

Ceftriaxone - 500mg Model of pack:500 mg Packing:Vial Ceftriaxone - 500mg TRICOCEF - 500 VIALS

TRICOCEF-SB-1.5 Ceftriaxone-1000mg + Sulbactam-500mg Model of pack:1500 mg Packing:VialK Ceftriaxone-1000mg + Sulbactam-500mg , TRICOCEF-SB-1.5 VIALS

Calocium Lactate + Vitamins Model of pack:200 ml Packing:Pet Bot Calocium Lactate + Vitamins , CECAL - 12 SYRUP

NIMICS – 200 Nimesulide - 200mg Model of pack:20x10's Packing:Blister Nimesulide - 200mg, NIMICS - 200 TABLETS

CETNAC & ndash; MR Each tablet contains - Diclofenac Potassium B.P. 50 mg Paracetamol I.P. 325 mg Chlorzoxazone U.S.P. 250 mg CETNAC – MR