Production Planning, Inventory Control, Raw Material Receipt, Packaging, Quality Control, Quality System, Self-inspection and audit, Product Development
The Company's Main Business and the Development of Consumer Demand
The main business carried out by PT Kimia Farma is producing medicines, not only that, PT Kimia Farma also produces beauty tools. The parts in producing drugs include the following:
Production Planning and Inventory Control (PPPI)
PPPI is led by a Manager who supervises two assistant managers, namely planning, controlling raw materials and production and storage processes. (PPB&PP). PPB&PP has the following functions and duties:
Evaluating and confirming orders from marketing/other units PPB&PP will plan materials and production processes according to orders from the marketing department every quarterly period. Based on the order, PPPI will confirm the ability to work with four possibilities, namely: the request is fulfilled according to the order, the order is partially fulfilled, the order is fulfilled in excess of the order or not fulfilled the order at all.
PPB & PP will calculate and plan the raw material/packaging needs including buffer stock. Material planning must be efficient, namely by optimizing material requirements. The methods used include: quantum of ability (in packaging units), breaking down the grains / bottles / ampoules to the number of batches. Look into the formula what ingredients are needed to make the item and in what quantity. Check the availability of materials, both in the warehouse and on orders. Calculating the required amount including buffer stock (1/3 of the next requirement), if less, a PR (Purchase Request) or SPPB (Material Order Request) will be made.
Controlling the stock of raw materials/packaging to be effective and efficient. The way to control the stock of raw materials and packaging materials to be effective and efficient is by monitoring the amount of usage per day, calculating carefully at the time of making purchase requests, setting a schedule for the arrival of ordered materials.
Storage
Storage is a part in charge of managing the receipt, storage, and expenditure of goods for the production process. The storage department is led by an assistant manager who supervises three supervisors, namely: a raw material warehouse supervisor, a packaged material warehouse and a central weighing. There are three storage functions at PT Kimia Farma Plant Jakarta.
1. Raw Material Receipt
Receipts made are the receipt of raw materials, finished materials, expedition materials and packaging materials needed for production purposes. The status of the newly arrived material belongs to the supplier who will be quarantined first by the storage party. Receipt of raw materials comes from local and imported. Future receipts of goods are treated according to their storage specifications. The goods that come are checked for conformity with the SP (Letter of Order). Visual inspection includes correctness of labels (name of ingredients, batch number), quantity, condition of packaging, origin, date of manufacture, expiration date, and CoA (Certificate of Analysis).
If it is appropriate, a Temporary Proof of Deposit (BTBS) will be made. BTBS is made in 3 copies, the original sheet is submitted to the supplier, copy 1 is for warehouse archives and copy 2 is a request letter for checking to QC.
Goods enter the quarantine warehouse and are labeled yellow. The quarantine warehouse will make an Inspection Request Letter (SPP) to the quality control laboratory section. After the inspection by means of a sample, the quality control party issues an HPL (Laboratory Examination Results) which states that the goods are approved or rejected. If the statement passes, the goods are labeled green with the words "PASSED" indicating that the goods are in accordance with the specifications for production. The warehouse will issue a Proof of Receipt of Raw Materials (BPBB) and the raw materials are stored in the warehouse based on their stability.
Meanwhile, rejected goods are given a red label which will be returned to the supplier by making a Letter of Return of Goods and attaching Laboratory Examination Results (HPL) for local goods, while for imported goods an official report is made and sent to the head office for further processing. Raw materials will be re-examined once a year. At least 12 days before the due date, the raw material storage department must submit a request for examination to the laboratory. During the re-inspection, the status of the goods is quarantined and labeled yellow.
2. Storage
After being released, the raw materials are transferred from the quarantine room to the appropriate storage area, namely warehouse A, B, C or D. The storage system is based on FIFO (First In First Out), the principle of storage is to make it easier to find so that on each shelf there is a list of available items. . In addition, the location of the goods has been mapped to facilitate the storage of goods back and expenditure. Storage warehouses consist of: warehouses A, B, C, D, fire warehouses, packaging materials warehouses, finished materials warehouses and expeditions.
Storage in warehouse A is conditioned at 30°C with 75% humidity which is monitored twice a day, at 09.00 and 14.00. Storage in warehouse B was conditioned at 30°C with 75% humidity which was monitored twice a day, at 09.00 and 14.00. This room is a warehouse for storing raw materials that have been released. Warehouse C was conditioned at 25°C with 70% humidity. In this room, the conditioning is carried out with the AC running for 24 hours. This warehouse stores primary packaging materials such as aluminum foil. Warehouse D is used to store both raw materials that are still in quarantine status.
3. Release of goods
The release of goods by the raw material warehouse, issued in accordance with orders for production purposes. The system for releasing goods is based on FIFO (First In First Out) or FEFO (First Expired First Out). The warehouse will issue goods not in the form of fractions but in the form according to the packaging from the supplier (in the form of boxes or barrels).
4. Central weighing
Central weighing is between the storage of raw materials and the production department. Weighing of raw materials is carried out after the SPK is issued from PPPI to the production department, then the production department will send the production plan and weighing of raw materials and Batch Management Records (CPB) to the central weighing. The CPB after weighing the materials will be returned to the production department.
Production
The production department is led by a production manager who oversees 4 Assistant Managers, namely Assistant Manager Production I, Production II, Production III and Packaging. The flow of the production process in each production section starts from the PPIC section which provides SPK to each production section accompanied by a Certificate of Request for Raw Materials (BPBB), Bon Request for Packaging Materials (BPBK), Bon 1, Bon 2, Bon 3, Bon 4, Bon 5 and Minutes of Production (BAP). The product development department will provide Batch Processing Records (CPB) and Batch Packaging Records (CPSB). BPBK will be forwarded to the packaging material warehouse, while BPBB and CPB will be sent to the central weighing then the raw materials that have been weighed will be sent to each production department to carry out production activities.
Production I
Assistant Production Manager I is a pharmacist, who is responsible for production activities I, namely the production of non-betalactam and Anti Retro Viral tablets. Assistant Production Manager I in his duties is assisted by 4 Supervisors, namely Granulation Supervisor, Tablet Printing Supervisor, Tablet Coating Supervisor and Anti Retroviral Person in Charge. The Anti Retro Viral (ARV) section is led by a technical person who is directly responsible for the production process in the ARV section to the Assistant Production Manager I. The ARV section produces drugs used for diseases caused by Retro Viruses such as HIV AIDS.
The ARV building is separated from the non-betalactam building and the beta-lactam building to avoid contamination of ARV products with other products. ARV products only consist of tablets and capsules packaged in bottles. The ARV production process is the same as the production of non-betalactam preparations, but for the production of ARVs, storage and weighing of active ingredients is carried out separately in the ARV area, not in the central weighing. PT Kimia Farma Plant Jakarta has special rights to produce and distribute narcotic drugs in Indonesia. The production of narcotic preparations is the responsibility of each related Asman according to the dosage form. In general, Asman Production I is responsible for narcotics management.
PT Kimia Farma Plant Jakarta conducted a toll out for Amoxicillin and Cefadroxil drugs in several pharmaceutical industries. The steps taken include: process validation will be carried out by the Product Development section in the contracting industry. PT Kimia Farma Plant Jakarta will prepare raw materials for production which will be sent to contract recipient industries. The contracting industry will produce in accordance with the procedures set by PT Kimia Farma. The analytical method from PT Kimia Farma will be transferred to a method, namely a comparative test with two analysts in triples for three days (18 times of testing). The results obtained will be tested by T-Test, the results of the T-Test will be decided whether there is a significant difference or not.
IPC (In Process Control) during the production of the first batch to the sixth batch will be carried out jointly (PT Kimia Farma Plant Jakarta and the contract recipient industry). If the results obtained meet the requirements, the next batch of testing will be carried out by the contract recipient, PT Kimia Farma will receive the CPB.
Production II
Production II is under the responsibility of the Assistant Production Manager II to handle non-betalactam capsules, creams, liquids and dry syrups and sterile products. Assistant Production Manager II is assisted by four supervisors, namely capsule supervisor, cream supervisor, liquid supervisor and sterile preparation supervisor.
Production III
Production III specifically produces beta-lactam antibiotics, namely Ampicillin and Amoxicillin. Beta-lactam products produced by PT Kimia Farma Plant Jakarta are divided into three dosage forms, namely tablets, capsules and dry syrup. The production process of beta-lactams is basically the same as the production of non-beta-lactam preparations, the process of making tablets is done by dry granulation.
Packaging
The packaging department is led by an Assistant Manager assisted by 5 Supervisors namely In-Process Quarantine Supervisor (KIP), Primary packaging Supervisor, Secondary packaging Supervisor, Solid preparation and Marking Supervisor. The packaging process begins after the bulk product is declared to have passed by QC. All products are packaged according to the specified packaging material formula. The finished product is packaged in the primary packaging and then put into the secondary packaging line according to the dosage form.
Quality Control (QC)
The quality control department is led by an Assistant Manager who supervises six Supervisors, namely Supervisor of raw material inspection, Supervisor of packaging material inspection, Supervisor of inspection of intermediate and bulk products, Supervisor of microbiological and waste inspection, Supervisor of finished product inspection, and Supervisor of production process supervision.
1. Raw material inspection
The raw material inspection supervisor supervises the sampling activity, sampling is carried out at the top, middle and bottom of the raw material container, then an inspection is carried out, then the quality control section provides the Laboratory Examination Results. If the HPL states that the raw material has passed the test, it is labeled green and the material can be used for further processing.
2. Inspection of packaging materials
Inspection of packaging materials that will enter the warehouse is also carried out based on a letter of request for inspection from the storage of packaging materials.
3. Inspection of intermediate and bulk products
Each stage of the production process has parameters for laboratory inspection by QC based on the application letter. Laboratory examination will sample intermediate or bulk products from KIP.
4. Microbiological and waste inspection
Quality control (QC) also checks the microbiology of antibiotic raw materials with antibiotic potency tests, while for non-antibiotic materials, it includes testing for penicillin contamination in production water once a week, in the production room once a month. Quality control also checks waste by testing pH, temperature, Total Solid Suspended (TSS), ammonia content, PO4, Biological Oxygen Demand (BOD) and Chemical Oxygen Demand (COD).
5. Production process supervision
Before carrying out the production process, QC must first check the initial production results to ensure the tool produces the right product, for example QC checks the thickness, diameter, and hardness of the tablet when it is first printed. If it passes the inspection, QC coordinates to the production supervisor that the production process may run, but if it does not pass the inspection, the QC recommends to the production supervisor that the production process should not run until it produces a product that meets the requirements. The supervisor of the production process supervision has responsibility for all quality control activities in the beta-lactam department as a whole.
6. Finished product inspection
After it becomes a finished product, it is still checked by an examination by the laboratory at the time of finishing packed. The inspection carried out is a visual inspection with the aim of preventing errors in the number and identity of the finished product that will be sent to the National Distribution Center (NDC). The finished product inspection supervisor is also responsible for all quality control activities in the ARV department as a whole.
Quality System
The quality system and product development fall under the quality assurance department. The quality system is led by an Assistant Manager who is assisted by five Supervisors, namely calibration, qualification and validation Supervisors; Self-inspection and audit supervisor; stability supervisor; Supervisor of document control and Supervisor of documentation, regulation and handling of customer complaints.
1. Calibration
Calibration is a series of actions to determine the similarity of values obtained from a measuring instrument or measuring system or displayed from material measurements and compare them with known values from a standard reference. Internal calibration, carried out by PT Kimia Farma (Persero) Tbk. Plant Jakarta with existing calibration tools. External calibration, performed by another company that has a standard calibrator. calibration of the tool according to the manufacturer's recommendations and adjusted to the frequency of use of the tool and the level of criticality of the use of the measuring instrument.
2. Qualification
Qualification is a system of assurance of an equipment related to the performance of its function along with the determination of certain value limits. There are 4 types of qualifications, namely design qualification which is the first element in the validation of new equipment, systems or facilities and is carried out based on user requests. Installation qualifications for new or modified equipment, systems and facilities include installation of equipment, pipes and supporting facilities as well as instrumentals (installation must be in accordance with technical specifications and drawings). Operational qualification is carried out when the installation qualification has been completed, proving that the operating parameters of the equipment function according to specifications. Performance qualification as proof of tool performance in accordance with the specified specifications.
3. Validation is an act of proving in an appropriate manner that each material, process, procedure, activity, system, equipment or mechanism used in production and quality control will always achieve the desired result. In carrying out validation there are several documents that must be, among others: Master Plan Validation (RIV) and Protocol Validation. RIV is a document that provides information about the validation work program. This document should provide a detailed schedule of the validation work to be carried out. A validation protocol is a written technical plan starting from how the validation will be carried out including test parameters, product characteristics, equipment and decision-making limits on acceptable test results.
PT Kimia Farma Plant Jakarta performs several validations, namely: Validation of analytical methods, is a process carried out to ensure quality through the correctness and suitability of the analytical methods used. Cleaning validation, the goal is to find out that the cleaning procedures that have been carried out have been effective. Process validation is carried out after the analytical method is validated and personnel receive training. Process validation is divided into 3 types, namely prospective, retrospective, and concurrent validation. Prospective validation is carried out for new products with the first 3 batches having to meet the requirements carried out at the Research and Development Section in Bandung.
Meanwhile, the Jakarta Plant only performs concurrent validation for monitoring the production process for 3 consecutive batches and retrospective validation on products already in circulation based on documentation from 10-30 batches.
Self-inspection and audit
The purpose of self-inspection is to evaluate whether all aspects contained in PT Kimia Farma Plant Jakarta. Self-inspection is carried out four times a year. Conducting a quality audit is useful as a complement to self-inspection. A quality audit includes the examination and assessment of all or part of the quality management system with the specific aim of improving it. There are two types of audits carried out at PT Kimia Farma Plant Jakarta, namely internal audits and external audits. Internal audit is an audit conducted on every part of PT Kimia Farma Plant Jakarta. The appointed auditors are from the company's internal circles, while external audits are audits that are carried out on part or all of the parts.
PT Kimia Farma Plant Jakarta conducted by an independent auditor from outside the company. PT Kimia Farma Plant Jakarta also conducts audits of drug transportation services for suppliers or other service providers. The audit of makloon, raw material suppliers and distributors is carried out once a year, while for packaging material suppliers it is carried out twice a year.
1. Stability
For stability testing is taken from 1% of the batch per year. Stability of new products, testing of test samples which include on-going and accelerated inspections. On going stability test was put into a climatic chamber at a temperature of 30°C ± 2°C with a relative humidity of 75 ± 5%. Test schedule 0, 3, 6, 9, 12, 18, 24, 36, 48, 60 months. Stability is accelerated by placing it in a climatic chamber at a temperature of 40°C ± 2°C with a relative humidity of 75 ± 5%. Test schedule 0, 1, 2, 3, 6 months. Stability testing of products that are already circulating in the market and it is still sufficient to carry out an on going stability test. The product is put into a climatic chamber at a temperature of 30°C ± 2°C with a relative humidity of 75 ± 5%.
2. Document control
Document control functions to replace, distribute and ensure documents that have changed. There are several levels of documents that are the responsibility of the document control department, namely level I for quality manuals, level II for quality system procedures, level III for fixed procedures and level IV for forms.
Product Development
Product development functions as a continuous improvement in product quality, cost efficiency, the need for packaging changes to attract consumers' attention, and technological developments. This section is led by an Assistant Manager who supervises two Supervisors, namely the Product Formula Development Supervisor and the Packaging Material Development Supervisor.
1. Product formula development
The function of product formula development is the handling of alternative raw materials, including finding sources for other suppliers to anticipate the unavailability of raw materials on the market that are exhausted and as cost efficiency. Product development will coordinate with the procurement department. Procurement will contact the supplier, the supplier will send a sample for inspection by the QC section and a production scale trial is carried out to see the stability and quality of the material. After the inspection results are known, it will be confirmed again to the supplier. Another function is the evaluation of the formula and production process, every time there is a change in production including changes in excipients, an evaluation will be carried out on these changes.
The Company's Main Business and the Development of Consumer Demand
Handling new products, the product development department prepares all needs starting from the processes, methods, technology needed when transferring formulas from the Research and Development Bandung. The product formula development department will also monitor and evaluate the distribution permit number. PT Kimia Farma (Persero) Tbk. has a registration staff at the head office who handles product registration. Product development at the Jakarta Plant will only report and prepare data and information needed by them in the distribution permit process and confirm products that need variation registration.
2. Development of packaging materials
The functions of the packaging material development section include: handling alternative packaging materials, including finding alternative sources of packaging material suppliers for the purpose of cost efficiency and preventing the unavailability of packaging materials in the market being depleted. The second task is the design of packaging materials, the product development department will design the packaging that will be used for both existing and new products. The third task is to evaluate the formula and packaging process, every change in packaging materials will be evaluated against these changes. The fourth task is standardization of packaging materials which aims to be applicable in general. The last task is to standardize the size of the master box and adjust its capacity for cost efficiency.
Occupational Safety, Health and Environment (K3L)
Occupational safety and health is the need of every worker. Local leaders have responsibility for the implementation of occupational safety and health efforts in their respective environments. To be able to implement K3 and environmental protection, the company prevents work accidents, fulfills and complies with applicable laws and regulations and K3 requirements. There are several facilities at PT Kimia Farma Plant Jakarta to ensure occupational health and environmental safety for all its employees. These facilities include: evacuation sites, polyclinics, sports facilities, fire extinguishers, Personal Protective Equipment (PPE).
The waste contained in PT Kimia Farma includes liquid waste from washing machines and production equipment, room sanitation and production employees, liquid waste left over from laboratory examinations, used solvents for reagents, used engine oil. Solid waste from expired drugs, production activities (dust from dust collectors, packaging of raw materials and damaged packaging), laboratory activities (so that samples expire), canteen waste, expired archives, garden waste. Gas pollution originating from production activities, boilers. Efforts to treat waste or contamination carried out by PT Kimia Farma Plant Jakarta include:
1. Solid waste and dust that fall into the category of Toxic and Hazardous Materials (B3) are not processed by themselves but are sent out with the cooperation of third parties, including PT. Prasada Pamunah Industrial Waste (PT. PPLI) and PT Wastec International. Liquid waste such as residual reagents from laboratories or IPCs are also sent to third parties.
2. Liquid waste from the production process is self-treated in a Wastewater Disposal Plant (IPAL). The processes required in wastewater treatment include physical, chemical and biological processes. The physical process is only carried out by filtering, namely filtering coarse impurities such as plastic, rubber and so on. While the chemical process passes through several stages. Waste from Anti Retro viral previously added sulfuric acid for destruction then NaOH for neutralization. The waste is drained and the beta-lactam waste is added with NaOH to break the beta-lactam ring until it reaches pH 11. Then the precipitation process is continued before the wastewater is flowed to the main waste treatment to be processed together with non-beta-lactam waste.
3. The next process is the neutralization process with the addition of lime water until it reaches a pH of 7-8. The addition of this lime solution by inserting it in a holding tank and circulating continuously.