GMP is a system that ensures that products are consistently manufactured and distributed according to quality standards. GMP is designed to minimize the risks involved in Biscuit Manufacturing production that cannot be eliminated through testing the final product. It mean food safety hazards (like hair piece inside of biscuit, minute size insects inside of biscuit shell) are not identified in final product testing whereas all tests of quality control like moisture, baking, pack weight, sealing are as per standards.

So ultimately there is a need to develop such a system that prevents / minimize product hazards. Below is comprehensive guidelines that summarized in understanding manner that what GMP includes in biscuit manufacturing. All pillars of GMP should be designed, implemented & monitored. When these areas are fulfilled as per below description then finally one main pillar is being performed on regular (sometime as per need) intervals with follow ups & close up of non-conformance. That pillar is Audits / Inspections; here frequency of inspections / audits can be designed keeping in view the implementation status of every pillar, compliance to defined SOPs, or continual improvement part.

In our case (CFL), main focus of inspections will be personnel hygiene, Raw materials, sub-processes (Sugar Grinding, Flour sifting, invert syrup, crumb grinding, weighing of RM) and finally product manufacturing processes from dough / cream to sandwiching & primary packing. Main Pillars of GMP1- EquipmentThe equipments and utensils used should be made of appropriate materials and design to prevent corrosion, dirt or any external chemical agent from altering the composition of ingredients used to manufacture a product.2- PersonnelThe employees performing various tasks must have appropriate educational qualification and training. They should wear proper protective gear like hand gloves and apron to prevent contamination and hazards. They are not allowed to consume food, drink, tobacco, cigarette smoking within the manufacturing premises. 3- Building and FacilitiesBuilding that houses the manufacturing unit should be of suitable design and size to accommodate all the equipments. Floors and ceilings should regularly be cleaned. Proper sanitation, ventilation and lighting are very important for sanitary as well as staff.

4- Raw MaterialsThe three most important things to be considered about raw materials are quality, storage and treatment. Make sure that the raw materials you purchase are of standard quality. Store and treat them properly to avoid contamination, heat, cold and moisture. Label them and take a small sample to test it for purity.5- Manufacturing ProcessEnsure that the process you use is proven to produce a pharmaceutical product of high quality. It should be fully controlled and clearly defined. Any change in the process must be evaluated. Each employee should be handed a process manual written in clear and unambiguous language. 6- RecordsKeep the records and results of sample tests for every batch so that the complete history of the batch, right from the raw materials to distribution, can be traced whenever required. 7- LabellingLabel is the statement of identity for any product. It should clearly mention the name of product, ingredients, batch number, manufacturing and expiry dates, and direction for use and warnings. 8- AuditsAuditing is done by an experienced auditor having a science degree or working experience in pharmaceutical manufacturing. Their responsibility is to identify the weaknesses where the firm needs to improve, complete the audit report and audit checklist. If a member firm is found to be poor in GMP compliance, it has to pass through a second audit.Simply put, GMP is not an instruction manual on how to manufacture pharmaceutical products. Its a series of principles to ensure an effective and quality manufacturing process.

SO on basis of above please design your SOP as separate document attached as a refresher for understanding of document development.

Good Manufacturing Practices ProcedurePurpose:As we are quality conscious manufactures (Coronet Foods Pvt. Ltd.) & purpose of this procedure is to provide guidelines on good manufacturing practices (GMP) being adopted for the manufacturing of cracker, cookies / Biscuits which will ensure that we are manufacturing biscuits with consistent quality every time. GMP guidelines are established to maintain the high quality standards of our products to ensure customer satisfaction.Scope:Manufacturing process of Biscuit being produced by CFL will adhere to GMP procedure. It will include from procurement, storage, sub-processes (Sugar Grinding, Flour sifting, invert syrup, crumb grinding, weighing of RM, fat extraction, egg emulsion) and finally product manufacturing processes from dough / cream to sandwiching & primary packing, FGS & distribution. ResponsibilityHoDs of all departments (Admin, Engineering, EHS, Production, Quality, Supply Chain & others) are responsible for implementation of this SOP at all levels of processes. Procedure:Now you are requested to please define above pillars in & add one thins very clearly that every pillar how respective HoDs or his sub-ordinate will ensure pillar execution. One example for your working further.One pillar: Personnel Hygiene:As food product is being manufactured & every lot or batch produced, packaged / labelled, tested and stored by workers / personnel & under the supervision of senior staff & management. These workers can carry microbial load on their hands, skin, in their hair, and in their digestive systems or respiratory tracts. These workers can act as a pathogens carrier that transmits microbes from persons to the food being handled them either at stage of receiving, dough making, baking, creaming or packing or other places like water supplies, and other workers, and thereby, create the opportunity to transmit food borne diseases.To prevent / minimize risks of pathogens transfer from person to product or person to person, they must follow below guidelines & to ensure implementation inspection / audits will be conducted on weekly basis under leadership of Quality manager: Proper hand washing / use of hand wash must be followed before entrance of working areas with sanitizers or soap. This is applicable after using restrooms, returning to their work station from break or lunch, or at any other time when their hands may have become contaminated. Use of PPEs: Must wear caps, beard / face mask, gloves & aprons during handling of product at respective place. Loose clothing is also not allowed in process area. Wearing of jewelry / ornaments is prohibited Nail polish use is also prohibited & nails must kept short & should be cleaned ones No edible item Toffees, Bubble gum, cigarette, Betal nut, betal leaf etc are not allowed to carry with himself / herself in Factory. Smoking is not allowed within factory premises & no smell shall be perceived from mouth Perfume spray is also not allowed to be used when coming factory Personnel must advise management when known to be suffering from a disease likely to be transmitted through food and will not be permitted to handle exposed food during period of illness. Health screening / medical checkup of employees on defined schedule may be checked from Social Security or as per need from third party. In very rare case with prior intimation, Injuries & open sores must be secured & protected by water proof color (not resemble to skin color) covering before performing work activities. Education / awareness of workers on personnel hygiene & their monitoring on compliance to this policy. Audit results recording into Personnel GMP Chart (must mention here Personnel Hygiene Chart document #.)Personnel Hygiene Checklist:SR.#ParticularsStatus

1. Are avoid touching nose, mouth, hair and skin during food preparation?

2. Are workers coughing or sneezing as per guidelines or directly onto food? Are they washing their hands after coughing or sneezing?

3. Are workers eating, drinking, and chewing food items in process area?

4. Are they wearing jewelry, rings or loose clothes?

5. Are workers using perfumes / shave creams having their smell / fragrance at time of food handling?

6. Are staff fit to work, wearing clean, suitable protective clothing and following personal hygiene rules particularly hand washing?

7. Are wash hand basins clean with warm water, soap and hygienic hand drying facilities?

8. Are wash hand basins used for hand washing only and used regularly by staff?

9. Have workers covered all wounds or cuts on hands or arms completely with bright-colored waterproof wound strip?

10. Are workers keeping their fingernails short and clean?

11. Are staff toilets and changing facilities clean and tidy?

12. No paper towels. Holder refilled and discussed with staff.