Sanitation: A high level of sanitation and hygiene should be practised in every aspect of the manufacture of drug products.

The scope of sanitation and hygiene covers Personnel, premises, equipment and apparatus, production materials and containers, products for cleaning and disinfection, and anything that could become a source of contamination to the product. Potential sources of contamination should be eliminated through an integrated comprehensive programme of sanitation and hygiene. Premises used for the manufacture of finished products should be suitably designed and constructed to facilitate good sanitation. There should be written procedures assigning responsibility for cleaning and sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used and facilities and equipment to be cleaned. Such written procedures should be followed. These programmes should be implemented; they should regularly be brought to the attention of the personnel involved and emphasized during continued staff training. Protective garments and other protective items appropriate to the processes being carried out should be worn. Eating, smoking, and unhygienic practices should not be permitted in manufacturing areas. The sanitation of clean areas is particularly important. They should be cleaned frequently and thoroughly in accordance with an approved written programme. Monitoring should be regularly undertaken in order to detect the emergence of resistant strains of microorganisms. In view of its limited effectiveness, ultraviolet light should not be used as a substitute for chemical disinfection. Disinfectants and detergents should be monitored for microbiological contamination; dilutions should be kept in previously cleaned containers and should only be stored for defined periods unless sterilized. Disinfectants and detergents used in grade A and B areas should be sterilized before use. In order to control the microbiological cleanliness of the various grades in operation, the clean areas should be monitored. Where aseptic operations are performed, monitoring should be frequent and methods such as settle plates, and volumetric air and surface sampling (e.g. swabs and contact plates) should be used. Documentation: Proper documentation is essential in almost every aspect of the pharmaceutical industry. Whether for product registration, factory inspection, or internal quality control. An important documentation habit for employees of pharmaceutical companies is to ensure that all information recorded by hand is legible. Every time an operator, inspector, or chemist records information, a second party must be able to accurately read what was written. With this in mind, pharmaceutical employees need to be careful when recording letters or numbers which can look similar to other ones. An example of this is when a chemist records a "9", but does not completely close the top of the number and it looks like a "4". This can

result in miscalculation and the acceptance of a product that should not pass acceptance criteria. Specifications (for starting materials, primary packaging materials, intermediate and bulk products and finished products), master formulae, and processing and packaging instructions may be changed frequently as a result of new experience in the development of an investigational product. Each new version should take into account the latest data and include a reference to the previous version so that traceability is ensured. Rationales for changes should be stated and recorded. Batch processing and packaging records should be retained for at least 2 years after the termination or discontinuance of the clinical trial, or after the approval of the investigational product. It is important to collect, with the samples, the relevant manufacturers analytical documentation, namely a copy of the analytical methods used by the inspected laboratory and the report of the analyses performed by the applicant on the batch sampled. An important purpose of documentation in the pharmaceutical industry is retaining documents. When an auditor is performing an audit on a company, he will request various documents to be pulled, for examination. As long as the documents are not beyond their pre-established deadline for destruction, the company must provide them. For this reason, document retention is an important habit in the pharmaceutical industry. Employees must retain the documents for which they are responsible. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they dont tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls. Record keeping: All documents associated with the manufacture of a batch of bulk product or finished product are called records. They provide a history of each batch of product and of all circumstances pertinent to the quality of the final product. Generally deviations in an instrument or process deviation are reported, investigated and recorded; records are made (manually and/or by recording instruments) during manufacture to show that all the steps required by the defined procedures and instructions have in fact been taken and that the quantity and quality of the product are as expected; records covering manufacture and distribution, which enable the complete history of a batch to be traced, are retained in a comprehensible and accessible form; A written report summarizing the results recorded and the conclusions reached should be prepared and stored in a legible manner. Any complaint concerning a product defect should be recorded with all the original details and thoroughly investigated. The person responsible for quality control should normally be involved in the review of such investigations. All decisions made and measures taken as a result of a

complaint should be recorded. Complaints records should be regularly reviewed for any indication of specific or recurring problems that require attention and might justify the recall of marketed products. The distribution records should be readily available to the authorized person, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall. Now a days electronic record keeping is gaining importance, Electronic record keeping plays an important role in helping pharmaceutical manufacturers build quality into the process. Paper records are cumbersome and expensive to circulate for review and approval when there are multiple staff members or departments involved in the process. This challenge is compounded in a global enterprise. Faster and cheaper product development, manufacturing and quality assurance turnaround is possible with electronic routing of signature requests anywhere, virtually and instantly. Electronic records also improve accuracy. There are limited means to prevent users from entering invalid data on paper forms beyond rigorous and time-consuming manual checking. Sophisticated electronic record systems, however, are adept at reducing data errors by providing users with lists of appropriate values from which to choose, and by validating data formats prior to accepting or saving the data into files or tables. Role of central council of Indian medicine: Central Council of Indian Medicine (CCIM) is a statutory body under Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Ministry of Health and Family Welfare, Government of India, set up in 1971 under the Indian Medicine Central Council Act, (Act 48) which was passed in 1970. It is one of the Professional councils under University Grants Commission (UGC) to monitor higher education in Indian systems of medicine, including Ayurveda, Siddha and Unani. The main role includes To prescribe minimum standards of education in Indian Systems of Medicine viz. Ayurved, Siddha, Unani Tibb. To advise Central Government in matters relating to recognition (inclusion/with drawl) of medical qualification in/from second schedule to Indian Medicine Council Act, 1970. To maintain a Central Register on Indian Medicine and revise the register from time to time. To prescribe Standards of Professional Conduct, Etiquette and Code of Ethics to be observed by the practitioners. And in brief to improve the actual assessment of teaching and practical training facilities along with the teaching staff in conformity with the Minimum Standards laid down by CCIM following action have been initiated. A more

challenging task which was accomplished by this Council was to prepare a database of all ISM (Indian Systems of Medicine) teachers. The aim of preparing the database was to keep a record of all ISM (Indian Systems of Medicine) teachers and to assess their eligibility. However, all efforts were made and prima facie data base has been prepared by the office. The data base of teaching staff along with their other details is being maintained in the office of CCIM and being updated time to time to rule out the duplicity etc. However, the database of teachers prepared by the Council became an important tool to stop the malpractice of teachers of ISM and colleges. It plays a role in Revision of Minimum Standards & Requirements of Ayurveda, Unani and Siddha colleges & hospital: Keeping in view of the requirements of all three Indian Systems of Medicine, minimum standards for Ayuveda, Unani and Siddha systems have been reviewed as per requirement of present scenario with the consultation of department of AYUSH and this matter is awaited for approval from GOI department of AYUSH (Regulation of minimum standards and requirements is not notified till today since inception of the council), and To maintain and update the Central Register of Indian Medicine as well as supply of updated as well as early submission of State Register and observance of the Professional Conduct and Etiquette, duties and obligations by the practitioner of ISM (Indian Systems of Medicine), also maintain the transparency, the minute details of Executive Committee and Central Council have been uploaded on the website of CCIM since establishment of CCIM i.e. 1971 to till date. CCIM has also been involved in regulating the Ayurveda, Siddha and Unani, Tibb education courses at the graduate and post-graduate streams. I also involved in the Appointment of teaching staff in Ayurveda, Unani & Siddha Colleges, and observing the Minimum Standards and Requirements strictly, the Management of the private college and State Governments have constructed the building to bring the area at par with the Minimum Standards & Requirements of the CCIM. It plays a key role in Updating of syllabus of various Under-Graduate and Post Graduate courses of Ayurveda, Unani and Siddha. Containers and closures: A container closure system refers to the sum of packaging components that together contain and protect the dosage form. A container sealed by fusion and to be opened exclusively by breaking. The contents are intended for use on one occasion only. : A pharmaceutical container is defined as device which holds the preparation into and which is in direct contact with the drug preparation throughout its shelf life. Ideal characteristics of pharmaceutical containers, 1. It should be non-toxic.

2. It should maintain the integrity of the product throughout its shelf life. 3. The design should permit easy removal of the dose. 4. The container and its closure must fit in the packing line 5. It should help in maintaining the stability of the photo sensitive drugs. Types of material used for making containers: 1. Glass: glass is primarily composed of sand and alkali oxides together with certain additives which are added to make the glass hard, water insoluble and colored. Glass is composed of sand oxides of alkali metals (Al, B, Ba, Ca, K, Na, Mg, Zn). 2. Metals: 3. Paper and board: The materials are considered to be the traditional part of packaging. These are used for preparing outer container and they provide additional support to the outer packing material. 4. Plastics: Plastics are the generally used packaging material during recent years, because of its advantages like lighter weight compared to glass, rigid, highly resistant to heat e.t.c. Closures: Closures are devices and techniques used to close or seal a bottle, jug, jar, tube, can, etc. Closures can be a cap, cover, lid, plug, etc. Types of closures : Screw top, crown cap, friction fit, dispensing, child resistant, threaded closures, plastic closures. Depending on the contents and container, closures have several functions: Keep the container closed and the contents contained for the specified shelf life until time of opening Provide a barrier to dirt, oxygen, moisture, etc. Control of permeation is critical to many types of products: foods, chemicals, etc. Keep the product secure from undesired premature opening Provide a means of reclosing or reusing the container Assist in dispensing and use of product Allow reasonable ease to open the container by the intended user. Difficult to open containers may cause wrap rage. The force or torque required to open a closure is an important consideration for packaging engineers.