Malladi Drugs & Pharmaceuticals Ltd is one of India 's most tradition conscious and ethically sound Pharmaceutical

Company. Malladi Drugs was founded in 1980 by late Mr. M L N Sastry, a pioneering microbiologist with expertise in fermentation technology. Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in the Cough and Cold segment along with a dominant presence in other therapeutic segments like Anti-histamines, Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global pharmaceutical industry.

Company Profile
Object 1

Company Name: Key Points: Business Type: Industry Focus: Geographic Markets: No. of Employees: Annual Sales Range (USD): Certificates: Year Established: Legal Representative/CEO:

Malladi Drugs & Pharmaceuticals Ltd.

ManufacturerManufacturerManufacturer

Pharmaceutical Chemicals,

1980

Thank you for having selected to visit the website of Malladi Drugs & Pharmaceuticals Limited from among the many many websites from around the world. We are sure you will have a pleasant time browsing through our website and getting to know us. Malladi Drugs & Pharmaceuticals Ltd is one of India 's most tradition conscious and ethically sound Pharmaceutical Company. Malladi Drugs was founded in 1980 by late Mr. M L N Sastry, a pioneering microbiologist with expertise in fermentation technology. Today, Malladi is the leading manufacturer of Active Pharmaceutical Ingredients (API) in the Cough and Cold segment along with a dominant presence in other therapeutic segments like Antihistamines, Anti-convulsants, Anti-depressants and Anxiolytics (CNS) of the global pharmaceutical industry.

Some of our noteworthy achievements are The first company in India to manufacture Ephedrine & Pseudoephedrine salts through a fully indigenous process. The first Indian company to acquire an API manufacturing facility out of India Novus Fine Chemicals in New Jersey, USA. We currently market our products in over 60 Countries and are supported by highly motivated and talented partners. At the heart of this pharmaceutical company there is desire to heal and contribute to the wellness of mankind. We are constantly innovating; Providing Value added services and always ensure that we have excellent relationships with everyone which encompasses our businesses and beyond

We are very competitive in the range of Products & Services that we offer; but more importantly, what sets us apart, are the relationships that we share with our valued customers. Malladi offers the following: Products Active Pharmaceutical Ingredients Steroids & Hormones and Molecules under Scale Up Speciality and Intermediate Product List Services
Contract Manufacturing

GMP compliant manufacturing Collaborative and non-competing business model Exclusive project working relationship for grams kilos- commercial Intellectual Property Protection Custom Synthesis Non-infringing processes Synthesis of API's and Complex Advanced Intermediates Biosynthesis of API's, Intermediates and Performance Chemicals Intellectual Property Protection Contract Research New Chemical entities Global patents Non-infringing processes Competently staffed- Doctorates in Organic Chemistry, Analytical Chemistry, Pharmacology and Microbiology

In-house process development and technology driven.

DEPARTEMENTS:

While in animal sciences department, tasks involved are providing cell cultures, growing microorganisms and taking care of animals used for discovery research. Bioinformatics is responsible for analyzing the data gathered from discovery research. Clinical Research: Once a potential drug candidate is determined, the clinical research department comes into picture. Clinical research is responsible for approving a drug from the Food and Drug Administration (FDA). It also determines the safety and effectiveness of the drug. The regulatory affairs function is responsible for ensuring all the requirements for FDA reporting are completed and submitted on time. Operations: The Operations department produces a salable amount of a drug. Once a drug has passed the clinical trials, the manufacturing and production department manufacture the final product, along with the packaging and labeling. Also housed under the operations umbrella is the environmental health and safety function, which assesses the environmental impact of a potential product. Quality: There are various rules and safety regulations laid down by the FDA for pharmaceuticals and biotech firms. If found guilty for drug contamination then the FDA may close the manufacturing plant of the firm. The Quality department of the pharmaceutical firm also ensures that the firm is adhering to government regulations. There are different groups which concentrate on functions like assurance, quality control as well as validation. These groups ensure that the drugs manufactured are accurate, and of a reliable standard of quality. Finance and Administration: The Finance and Administration department comprises different functional areas including finance, administration, legal and information systems. Responsibilities include managing activities related to finance management, handling legal relations with employees, investors, creditors as well as government regulators. Business Development: The Business development function recognizes potential fresh coalition partners and also handles previous alliances. They are responsible for market research, recognizing potential customers and preparing the promotion and pricing strategy. Project Management: Most of the pharmaceutical companies have a separate project management department. This department is responsible for coordinating the functions of all departments and also ensures smooth and efficient functioning. The Project management department also monitors particular projects. Malladi Drugs & Pharmaceuticals Head Office , Company Details, Financial Details Malladi Drugs & Pharmaceuticals Head Office Address : Door No. 9 GST Road ST Mount Chennai : 600016 Tamil Nadu ,India . Malladi Drugs & Pharmaceuticals Phone Number : (44) 39876900

Malladi Drugs & Pharmaceuticals Website : www.malladi.co.in Malladi Drugs & Pharmaceuticals Financial Details : No of Employees 501-1000 Turnover in Crs 10-100 Crs Sector- Private Sector

Mr Siva Prasad Rao(Manager) +(91)-(877)-2221221 +(91)-9704678548 Plot No.49, 50, IDA Gajulamandyam, Renigunta, Tirupati, Tirupati Ho, Tirupati - 517501

QUALITY CONTROL PROCEDURE IN PHARMACEUTICAL INDUSTRY

The word Quality refers to the characteristics of a product from both qualitative and quantitative point of view. It refers to the quality of process as well as the product itself. The word Control implies a procedure by which decisions may be made regarding whether production is proceeding according to the plan and meeting the standards established previously. The quality of a pharmaceutical product is standard, which is designed after a long research and development. Here quality does not concern with active substance but the quality depends upon many other factors such as excipients and product development procedures. The pharmaceutical industry is responsible to design, test and produce dosage form, which provides quality, purity, stability, safety, uniformity of contents and physiological availability to the consumer. THE AUTHORITY OF PROCESS CONTROL The maintenance of quality of a drug depends upon each and every person and setup in industry. To provide Quality Assurance; Quality Function and Quality Control must be maintained. Quality Assurance: Quality Assurance means that it can be said with confidence that Quality Function is being performed adequately the Quality Assurance group of company provides a strict supervision in all parts of each step. Its function is to inspect various phases of production so that the final product should be of highest quality. The monitoring of records, procedures, systems, facilities, labeling personnel and performing tests is the responsibility of Quality Assurance Group. The Quality Assurance may be the part of Quality Control Department or it may work independently under its own manager. Quality Variation: When the quality of any drug is given by industry, then it is responsible for any variation from the standard. Quality Variation may occur due to any mistake during the whole process i.e. from the reception of raw material up to the final product in the packaged form. The risk of error increases as the material increases and the method become very complicated. The general sources causing product Quality Variation during manufacturing are as follows: SOURCES OF VARIATIONS: 1. MATERIALS: a. Variations among suppliers of same substances. b. Variations among batches from same suppliers. c. Variations within a batch. 2. MACHINES: a. Variation of equipment of same process.

b. Difference in adjustments of equipment. c. Aging of machines and improper care. 3. METHODS: a. Wrong procedure. b. Inadequate procedure. c. Negligence in procedure by chance. 4. MEN: a. Improper working conditions. b. Inadequate training and understanding. c. Lack of interest and emotional upheavals*. d. Dishonesty fatigue and carelessness. QUALITY VARIATION CONTROL: The mistakes can be controlled, minimized or eliminated by material control; packaging control and GMP variations can be controlled when Quality Control, Quality Function, and Quality Assurance work side by side. * Upheavals: a violent or sudden change or disruption. Material control. CONTROL PROCEDURE: Controlling each and every step of process can control variations. Control can be divided into: Manufacturing practice control. Packaging control. Distribution control. MATERIAL CONTROL: It starts just after the reception of materials. Most of the materials that are active substances, excipients, packaging and printed materials are received by the industry from suppliers. Thus there should be adequate established system for the receipt, testing and storage of all these supplies. There should be a complete record of all the procedures and tests. In the material following things are included: Drug substances. Excipients. Packaging and printed materials. After the reception of material, it is kept in a definite area. Thus before laboratory testing, proper containers, labels, lot number, expiry dates etc all are checked. The material is stored in a proper way either they are arranged alphabetically or they are differentiated depending upon physical nature. Then samples are taken for laboratory testing and a label (Sampled) is fixed on material. In case of active constituents, percentage purity, adulteration, expiry date, lot number, exact packing etc is checked. In case of printing and packaging material especially the color of label, weight of label and cartons and grammage etc is checked. If the material is up to the mark, then a label (Passed) is pasted on it and it is placed at its proper place. On the other hand, if it is substandard, then it is kept in Rejected Area and sent back to the supplier. MANUFACTURING PRACTICES CONTROL: Successful GMP is difficult to attain but to some extent, it can be modified and controlled. Specific procedures can be applied to attain the best quality.

In case of manufacturing, following controls are important: Personnel. Equipment and building. Control of record. Production procedure control. (A). PERSONNEL: Usually properly educated and well-trained persons should be in the industry. There should be proper selection and training in all departments i.e. production, packaging, labeling, etc, etc. There should be general lectures for less educated persons who work in the labeling or packaging section in an understandable language. They should be made aware of the fact that what is the importance of life saving. They should be warned about all the dangers of their mistakes and errors. There should be properly educated supervisors working above the workers. The supervisors should always be there so that in case of any trouble or question, they must be available. All the workers should be properly checked and all the processes at different steps should also be monitored by highly educated and experience persons who may not only be well qualified but experienced as well. (B). EQUIPMENT AND BUILDING: The equipments and building used in storage, processing, checking and packaging should be of a suitable design, size, construction and location. In case of equipments, these should be constructed in a proper size and proper way. The size should be such that complete batch can be processed all at once. The surfaces of equipments should be non-reactive, non-absorptive and non-additive. The equipment should be constructed and fitted in such a way that it is easy to replace, easy to wash easy to operate and easy to empty. In case of building, there should not be any contamination i.e. the tablet and liquid section should be separated completely and even there should be complete separation in tablet machines. It means that machines should have separate cabinet. (C) CONTROL OF RECORD: The records such as master formula record and batch production record must be maintained. 1. MASTER FORMULA RECORD: a. The master formula record must be prepared for each product. b. It must be signed by a competent and responsible person. c. The language must be so that it may not be miss-interpreted. d. It should be checked by another competent person and must be countersigned. e. The master formula varies from production to production and from batch to batch. f. Master formula record include the following information: i. Name of the product, dosage form and strength. ii. Complete list of ingredients including excipients. iii. Quality by weight or volume of each and every ingredient. iv. Standards or specifications of each ingredient. v. Any calculated excess of an ingredient. vi. Theoretical yield and termination of process. vii. Manufacturing and control instructions, specifications and precautions. viii. Complete description of closures, containers, labeling, packaging and other finishing material.

2. BATCH PRODUCTION RECORD: a. Batch production record must be prepared, maintained and controlled for each batch of a product. b. It must be retained for about 5-years after product distribution. c. Batch production record should have following information in addition to master formula record. i. Batch number. ii. Code number. iii. Manufacturing date. iv. Expiry date. (D). PRODUCTION PROCEDURE CONTROL: The processes of manufacturing are operated according to the established rules from the reception of material up to delivery of final product. A complete list of ingredients along with their quantities is delivered to the Production Department. It is called Master Formula of that batch. It contains all the information of that batch i.e. procedures and equipments to be used and precautions to be taken, etc, etc. This master formula is taken into the store and all the materials for the batch are weighed and delivered to Production Department. All ingredients are rechecked and tested in laboratory. In the production procedure control, some tests are done during the process, which is called In Process Quality Control (IPQC) The IPQC is under Quality Control Department. Both Quality Control and Production Departments are responsible for the production procedure control. IPQC tests for different dosage forms are as under: 1. IPQC TESTS FOR TABLETS: a) Drug contents determination. b) Moisture contents of granules. c) Assay of active ingredients. d) Weight variation of uncoated tablets. e) Hardness test. f) Disintegration test. 2. IPQC TESTS FOR SYRUPS AND SUSPENSIONS: a) Drug contents determination. b) Assay of active ingredients. c) pH. d) Weight per ml. e) particle size 3. IPQC TESTS FOR SEMI-SOLIDS: a) Drug contents determination. b) Assay of active ingredients. c) Uniformity and homogeneity test. d) Viscosity and specific gravity test. e) Filling test. f) Leakage test. 4. IPQC TESTS FOR INJECTABLES: a) Drug contents determination. b) Assay of active ingredients. c) pH.

d) Pyrogen test. e) Stability test. f) Leakage test. g) Check up of particulate matters. PACKAGING CONTROL: The packaging control is usually completed before manufacturing of product. When the product come in packaging section, it should be packed in recommended containers and there should not be any mistake in case of labeling and writing of batch number, etc, etc. The packaging material is used according to the nature and distribution of product. DISTRIBUTION CONTROL: The responsibilities of Quality Control Department are not finished even after the distribution of finished dosage form in the market. The samples of each batch are kept in record and these samples are selected during packaging and are in the same packs as they are marketed. These are kept for years in order to examine or test the material for any purpose or necessary demand. QUALITY CONTROL AND ITS ORGANIZATION What is quality? QUALITY: It is a combination of all the characteristics of a product that determine the degree of acceptability of the product. The PMA (Pharmaceutical Manufacturing Association) says that the quality of a product is its degree of possession of those characteristics designed and manufactured with and which contribute to the performance of extended functions when the product is used as directed. The central idea of Quality Control is that quality must be built into the product during research and development and production. Central control as it applies to pharmaceutical industry is the organized effort within an entire establishment to design product and assure the specified quality in each unit of product distributed. It the responsibility of pharmaceutical company to design tests and procedures to produce dosage form that contains exact quantity and quality of drugs, which is acceptable, reproducible, convenient and elegant. PRODUCTION CHARACTERISTICS: The most important pharmaceutical characteristics are: Identity. Purity. Potency. Uniformity. Stability. Safety and efficacy. Physiological availability. Therapeutic activity. ORGANIZATION OF QUALITY CONTROL: The individual responsible for the quality of drug product in a pharmaceutical company is generally the director of Quality Control. He should report to the president or vice-president and should be on the same organizational level as that of Production Manager. Only the highest level of management should review his decisions about quality. A. ORGANIZATIONAL CHART OF QUALITY CONTROL:

President Vice-President Director/Manager

Analyst Supervisor Quality Control & Quality Assurance B. FUNCTIONAL CHART OF QUALITY CONTROL: President Director

Specification & Analytical Department Biological Testing Laboratory Central Release Office Inspection & Checking Chemical Testing Laboratory

There are five departments of functional Quality Control chart. These are discussed one by one. 1. SPECIFICATION AND ANALYTICAL DEPARTMENT: Quality of the finished product depends upon quality of the raw material used in the manufacturing operation. This department is responsible to analyze raw material and the product according to the specifications. Following are the specifications, which must be considered to maintain quality of the product. Solubility. Identification. Particle size. Surface tension. Loss on drying. Residue on ignition. Crystal shape. Viscosity, etc, etc. These are the specifications originated by the efforts of Quality Control research during product development. All specifications include those requirements, which are applicable to federal and state

Governments official compendia. The major cost of Quality Control lies in the testing of product throughout manufacturing operations. 2. CHEMICAL TESTING LABORATORY: Every lot of every shipment of raw material and every lot of finished product, which can be controlled by physical and chemical tests, is tested in the Chemical Testing Lab. This requires a well-equipped chemical lab properly staffed for better performance of great number of chemical analysis. It should be located in an accessible area and protected from noise and vibrations common in manufacturing operations. 3. BIOLOGICAL TESTING LABORATORY: A number of finished products require biological assay. Biological tests are not confined to a group of products recognized as biologicals in drug industry; since a number of pharmaceutical products such as parenterals require sterility and pyrogen testing before release to market. Biological lab should have essential animals. The staff in the biological testing lab should be well trained. 4. CENTRAL RELEASE OFFICE: The record resulting from the exercise of Quality Control functions throughout all the steps of manufacturing and packaging operations are voluminous. Quality Control organization is responsible to check these records. The record provides complete history of each lot of each product manufactured and therefore makes it possible to construct the relevant features of any package distribution into the market. The assay and access of central release office to records together with its liaison** with all manufacturing and packaging operations makes it possible for the group to investigate customers complaints about product quality. 5. INSPECTION AND CHECKING: The responsibility for inspection and sampling of every shipment of raw material received and every lot of finished goods turned over for distribution falls within the province of Quality Control Inspectors. The selection of samples of raw material and finished goods is an important aspect of Quality Control function.

** Liaison: communication and co-operation. SPECIFICATIONS FOR PACKAGING MATERIALS: BOTTLE: Capacity. Material (Glass, Plastic, Aluminum). Weight of bottle. Thread of bottle. Cap material (Rubber, Plastic coated). Thickness. COTTON:

Type. Moisture contents. SILICA BAG: Weight. Capacity. CARTON: Dimensions (Notches, Locking system). Quality of Board (Grammage). Printings. Color (lovibond, Tinctometer is used; the local industries have an album of colors). LABEL: Dimensions. Printing. Weight. Striations (Lines on Paper). Summary FLOW CHART-1 QUALITY CONTROL PROCEDURE 1) AUTHORITY OF PROCESS CONTROL. 2) QUALITY ASSURANCE. 3) QUALITY VARIATION. a. SOURCE OF VARIATION i. Material ii. Machine iii. Method iv. Men 4) QUALITY CONTROL OF VARIATION. a. MATERIAL CONTROL b. MANUFACTURING PRACTICES CONTROL a. Personnel b. Equipment & Building c. Control of Record i. Master formula record ii. Batch production record c. PRODUCTION PROCEDURE CONTROL a. IPQC for Tablets b. IPQC for Syrups and Suspensions c. IPQC for Semisolids d. IPQC for Injectables d. PACKAGING CONTROL e. DISTRIBUTION CONTROL FLOW CHART-2 QUALITY CONTROL AND ITS ORGANIZATION 1) ORGANIZATION OF QUALITY CONTROL 2) ORGANIZATIONAL CHART OF QUALITY CONTROL

PRESIDENT VICE-PRESIDENT DIRECTOR/MANAGER QUALITY CONTROL AND QUALITY ASSURANCE SUPERVISOR ANALYST 3) FUNCTIONAL CHART OF QUALITY CONTROL a) PRESIDENT a. DIRECTOR i. SPECIFICATION AND ANALYTICAL DEPARTMENT ii. CHEMICAL TESTING LABORATORY iii. BIOLOGICAL TESTING LABORATORY iv. CENTRAL RELEASE OFFICE v. INSPECTION AND CHECKING