Pharmaceutical Guidelines

Standard operating procedure of Dehumidifier used in Production area.

To describe the procedure for validation of microbiologist.. This SOP is applicable for the validation of microbiologist. Officer/ Executive - Quality Control 5.1 Samples of known analytical results shall be identified by Quality Control Manager for analysis in triplicate with three different identification no.6.2 The analytical result(s) of sample(s) along with acceptable limit(s), AR no., and code no.

To lay down the cleaning procedure for Colloidal Mill. This SCP shall be applicable for Colloidal Mill used in Coating area in Production department. 3.1 Execution :Operator 3.2 Checking :Pharmacist and Above HOD-Production 5.1 Put "OFF" the electrical supply and cover all electrical parts with poly bag.

Dissolve about 350 mg of Calcium Citrate, previously dried at 150°C to constant weight and accurately weighed, in a mixture of 10 ml of water and 2 ml of 3N hydrochloric acid, and dilute with water to about 100 ml. While stirring, add about 30 ml of 0.05 M Edetate Disodium from a 50 ml burette.

To describe the procedure for the enumeration of spore count in Biological Indicators. This SOP is applicable for the enumeration of spore count in Biological Indicators. Microbiologist - Quality Control Manager - Quality Control 5.1 Aseptically transfer one specimen paper strip of biological indicator to 1 ml of chilled sterile distilled water in a sterile 20x150 mm screw capped tube with 5 sterile glass beads of 4-5 mm diameter.

To lay down a procedure for vehicle Inspection. This SOP shall be applicable for inspection of vehicle by Stores Department. 5.1 Store person shall confirm that the vehicle is received from Approved Transporter. 5.2 The store person shall verify physically that no harmful material is loaded along with plant Materials.

To lay down the cleaning procedure for pallet. This SCP shall be applicable for cleaning of pallets used in Manufacturing and Packing area in Production department. 3.1 Execution :Operator 3.2 Checking :Pharmacist and Above HOD-Production 5.1 Wipe out the pallet with clean dry lint free cloth.

To lay down a procedure for preparation of microbiological culture media and plates & slants. This SOP is applicable to the Quality Control Dept. Microbiologist Head Quality Control Department. 5.1.1 Balance 5.1.2 Dehydrated media 5.1.3 Autoclave 5.1.4 Laminar air flow 5.1.5 Glassware 5.2.1 Store the dehydrated media in tightly closed packs in dark or as directed by the manufacturer.

To define the operation of the instrument for better and error free use of the same. This procedure is applicable to mix the solution or to dissolve the various substance in to solvent. Doing : Technical Assistant / Executive Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008.

To lay down the procedure for operation and cleaning of fogger. This is applicable to Microbiology lab. 5.1 Plug the machine into an appropriate power source as specified on the machine identification label. If an extension cord is being use, assure that it is of the proper rating.

To provide a system for allocating identification number to instrument/ equipment in order to have better tracebility and reference in all related documents. This SOP applicable to all instruments and equipments installed in quality control laboratory. Give identification no.

To provide a system for allocating document protocol number for instrument qualification in order to have a better tracebility and reference. 5.2 Document protocol number Applicable for XXX/Q.C./000 User requirement specification Functional requirement specification Allot following code for the protocol with respect to instrument qualification.

Thin-layer chromatography is a technique in which a solute undergoes distribution between two phases, a stationary phase acting through adsorption and a mobile phase in the form of a liquid. The adsorbent is a relatively thin, uniform layer of dry finely powdered material applied to a glass, plastic or metal sheet or plate.

To destroy the in-process, finished product and raw materials samples timely after testing in order to avoid any mix up or misuse of the same. This procedure is applicable for discarding the samples of in-process, finished product and raw material sample after testing to avoid mixing.

Standard operating procedure to store and use of Reagents and Chemicals in Quality Control.

To lay down a procedure for operation of particle counter. The procedure is applicable for operation of particle counter "Met one 3400". Officer/ Executive - Quality Control Manager - Quality Control 5.1 Logging in: Switch ON the main power, enter 'Counter Navigation' then enter 'Factory'.

To lay down the procedure for receiving the samples in microbiology lab. It is applicable to microbiology lab. 5.1.1 Microbiology personnel shall perform the sampling and collection of the samples required for microbiology and chemical testing. 5.1.2 After collection of the samples microbiology personnel shall allot the A.R No in the respective register.

To evaluate the uniform quality of D.M. water and W.F.I by trend of the results. This procedure gives guidelines for evaluating the results and to take corrective action if the results exceed action level. Doing : Technical Assistant/Executive Purified Water : For each critical sampling point, prepare a trend report once in a week for following critical parameters.

To lay down the cleaning procedure for multi mill. This SCP shall be applicable for multi mill used in Manufacturing area in Production department. 3.1 Execution :Operator3.2 Checking :Pharmacist and Above HOD-Production 5.1 Put "OFF" the electrical supply and cover motor, starter with polythene bag.5.2 Remove hopper, cover (chamber), screen guard, and blades by opening of wing nut then clean with 50 liter Potable water.5.3 Further clean with 2.5 % "Teepol" solution using scrubber.

Standard operating procedure to clean and disinfect the drains in Production area.

To lay down procedure for cleaning and maintenance of boilers. This SOP shall be applicable for cleaning and maintenance of boilers in utility block. Operator/Officer 5.1.1 Clean the boilers by using the dry cloth. 5.1.2 Remove the water filter and clean it by soft water.

3.1 Wear a protective garments, nose mask and hand gloves prior to start the destruction of microbial waste. 3.4 Add a 3.7 For 3.9 Start the autoclave as per 3.13 Collect the autoclaved material is 3.14 Drain out the media with flow of water, rinse the glassware with water and clean the glassware as per 3.2 Collect and transfer all used microbiological media, cultures and contaminated glassware to washing area.

To lay down the procedure for operation of data logger. This procedure is applicable to perform Heat distribution study in Instrument DHS, Sterilizer, Oven (55°C) & Walk-In-Incubator.

To lay down a procedure for preparation, approval, authorization, control and revision of general test procedure (GTP) in order to achieve uniformity. This procedure is applicable for GTP prepared by the Q.C department. 5.2 Describe analytical test procedure step wise in general test procedure to simplify the analytical procedure. a.

To define the cleaning procedure. This procedure is applicable for the cleaning of Tablet Hardness Tester. 3.1 Doing : Technical Assistant 3.2 Checking : Executive/ Manager Head of the Department Frequency : Daily 5.1 Pull mains plug before opening the housing. 5.2 Wipe off the instrument housing and the touch sensitive keypad with a cloth.